Exactech Recall Lawsuits

Rosenfeld Injury Lawyers represents individuals across all 50 states in Exactech recall lawsuits involving defective implants for the knee, hip, and ankle. Patients who received a recalled implant and have experienced pain, implant loosening, swelling, or required surgery for revision may be entitled to financial compensation.  

The Exactech litigation has evolved significantly, with key developments impacting current and future claims: 

• Exactech declared bankruptcy in October 2024, raising questions about compensation availability for victims.
• Multidistrict litigation (MDL) in federal court is progressing, with bellwether trials scheduled for July 2025.
• State court cases in Florida and other jurisdictions continue to grow, adding another legal front to the litigation.
• Settlement discussions are ongoing, with concerns that Exactech’s limited insurance coverage may affect final payouts.

This page provides critical updates on the Exactech lawsuits, including how the bankruptcy may impact claims, what to expect from upcoming trials, and how potential settlements compare to past defective medical device cases.

What You’ll Find on This Page:

• Latest case updates from federal MDL and state court lawsuits and how many Exactech lawsuits there are 
• Legal insights on how the litigation is unfolding
• Projected settlement estimates based on similar defective implant lawsuits
• Key deadlines and what you need to do if you have recalled implant devices

If you or a loved one received Exactech implants devices for the knee, hip, or ankle and have experienced complications or required revision surgery, contact our legal team today for a free consultation.  

Exactech Lawsuit: Defective Ankle and Knee Replacement Systems Lead to Recall

Exactech is a leading medical device manufacturer that provides knee, hip, and ankle implant systems used in joint replacement surgeries. However, the company issued a wide-scale recall after discovering that packaging defects caused premature degradation of a critical polyethylene insert component, leading to early implant failure in defective Exactech implant devices.

The Exactech recall applies to any knee replacement implant system that was manufactured in 2004 or later. Due to oxidation caused by improper packaging, the polyethylene inserts broke down before implantation, significantly increasing the risk of early device failure. Some patients experienced implant loosening and severe pain within months of hip or knee replacement surgery, forcing them to undergo corrective revision surgery far earlier than expected.   

In response, thousands of affected patients have pursued Exactech knee device replacement lawsuits, which led to a class action in 2022. Litigation is moving forward, with bellwether trials scheduled for 2025.

Filing an Exactech Hip, Ankle, or Knee Replacement Surgery Lawsuit

Anyone who has undergone knee replacement surgery using an Exactech implant system in the last decade may have grounds for a product liability lawsuit. With the recent surge in Exactech implant recall lawsuits, individuals who suffered implant device failure, required revision surgery, or experienced serious pain and mobility issues could be eligible for financial compensation covering: 

• Pain and suffering caused by implant failure
• Medical expenses, including costs for revision surgery
• Lost wages due to extended recovery periods or disability 

Our Exactech recall attorneys are currently reviewing claims from individuals who received recalled Exactech knee replacement systems, including the Optetrak® and Truliant® knee implants. If a defective Exactech knee replacement system has impacted you, contact us today to discuss your legal options and determine if you qualify for a lawsuit.   

Exactech Recall Lawsuits Our Firm Is Handling in 2025

Our law firm actively represents individuals nationwide in Exactech implant recall lawsuits involving defective implants for the knee, hip, and ankle. You may be entitled to financial compensation if you or a loved one received an implant that was recalled and experienced complications. This ongoing Exactech litigation involves significant developments in both federal and state courts. 

We are currently accepting Exactech implant lawsuits for the following recalled devices:

Exactech Knee Devices

• Truliant Knee Replacement Implant System
• Optetrak Logic Implant
• Optetrak Knee Replacement System  

Exactech Hip Devices

• MCS GXL Hip Device
• AcuMatch GXL Hip Replacement System
• Novation GXL Hip Implant
• Connexion GXL Hip Implant

Exactech Ankle Device

• Vantage Total Ankle Replacements packaged in defective bags 

Individuals who received any of these Exactech knee, hip, or ankle implants, including those involving the ankle replacement implant system, and required revision surgery or experienced implant failure should consider filing an implant recall lawsuit. Additionally, if you suffered bone loss or serious pain related to a defective product, legal action may be possible. 

Exactech Class Action Updates – November 2024

November 2024 Update: Bankruptcy Filing Changes Litigation Strategy

The Exactech MDL saw 36 cases in October, pushing the total number of lawsuits to 1,806. However, with Exactech declaring bankruptcy in early November, future cases face new procedural challenges.

When a company declares bankruptcy, a stay is automatically issued that pauses most pending litigation and prevents new lawsuits from being filed against the company unless approved by the bankruptcy court. Plaintiffs who intended to file new lawsuits must now submit claims directly through the bankruptcy proceedings. 

What This Means for Plaintiffs   

Despite Exactech’s bankruptcy, there’s no need for plaintiffs to be discouraged. Insurance policies and corporate assets are still available to compensate victims, and legal teams fight for maximum settlements. 

Key Bankruptcy Hearings and Legal Developments 

• October 30, 2024 – First bankruptcy hearing
• January 9, 2025 – Status conference to update on bankruptcy proceedings
• Ongoing – Every 90 days, joint status reports are required to keep track of developments.

With all other MDL deadlines adjourned indefinitely, the focus remains on how the bankruptcy court will handle injury claims and whether a global settlement is still a viable outcome. 

Exactech’s Response to the Lawsuits

Darin Johnson, Exactech President and CEO, released a statement acknowledging the company’s liabilities from the implants that were recalled. 

Exactech Class Action Lawsuit Updates – October 2024

October 2024 Update: Bellwether Trial Schedule Finalized, Litigation Moves Forward

An order was issued by the court granting parts and rejecting parts of the joint bellwether pretrial schedule proposed by both parties in the Exactech MDL. As a result, the first two bellwether trials have been formally scheduled:

• First Bellwether – Tarloff (Case No. 23-CV-5793): September 29, 2025
• Second Bellwether – Larson (Case No. 22-CV-6643): November 10, 2025

The court has directed Exactech lawyers for both sides to meet with Magistrate Judge Marcia M. Henry. This will take place on January 9, 2025, where they will address any discovery issues that still remain. Following this consultation, attorneys must provide a proposal for the pretrial schedule for the initial two bellwether trials.

Additionally, 100 more lawsuits became part of the Exactech MDL within the past 30 days, bringing the total pending cases to 1,770. Hundreds more cases remain pending in state courts in Florida. 

The focus is now shifting toward bellwether trial preparation, with Exactech lawyers expecting significant developments before the first trial. Some legal experts anticipate a potential global settlement before the first trial date, but no final agreement has been reached. Additionally, a state court trial may proceed in December 2024, marking the first trial related to Exactech claims outside the federal Exactech implant recall MDL.

Exactech Class Action Lawsuit Updates – September 2024

September 2024 Update: Bellwether Trial Dates Confirmed

The Exactech implant MDL continues to expand, with 1,670 cases pending as of September 2024. Although only 50 new cases were added during the summer, the litigation is moving forward with a more precise trial schedule.

The court has now officially scheduled two initial bellwether trials:

• Gayle Tarloff v. Exactech (23-CV-5793) – Trial Date: July 6, 2025
• Geraldine Larson v. Exactech (22-CV-6643) – Trial Date: September 29, 2025

While these trials are progressing, many Exactech lawyers predict that a global settlement may be reached before trial. However, preparations for trial remain active, as no formal settlement offer has been announced.

The next court hearing is scheduled for October 2, 2024. Before the hearing, Exactech lawyers are required to file a joint status report.

Exactech Class Action Lawsuit Updates – August 2024

August 2024 Update: Bellwether Trial Dates Pushed Back

The Exactech MDL judge has approved a joint request from plaintiffs and defendants to delay the first two bellwether trials.

• The first bellwether trial date was moved from July 2025 to August 2025.
• The second bellwether trial date was changed from August 2025 to September 2025.

This delay is primarily to allow additional time for discovery, following a recently announced Exactech implant recall that could affect key issues in several bellwether cases.

Additionally, the judge approved a request to modify the order of bellwether trials, allowing attorneys to address newly emerging evidence before proceeding with cases that may set the stage for a global settlement. 

Why Are These Delays Significant? 

Although delays in bellwether trials are usually seen as setbacks, this postponement of 60 days suggests that both sides may be preparing to take these cases to trial rather than rushing into settlement negotiations. This could indicate that attorneys are focused on determining the true settlement value of Exactech lawsuits before entering into large-scale negotiations.

Additionally, a recent transfer order added several new cases to the Exactech implant recall MDL, further expanding the litigation. However, July 2024 was relatively slow, with only minor docket updates and attorney filings recorded.

Exactech Class Action Lawsuit Update – July 2024

Revised Pretrial Schedule as Litigation Moves Toward 2025 Trials

The court has approved modifications to key pretrial deadlines in the Exactech implant recall MDL, ensuring Exactech lawyers on both sides have additional time for expert witness evaluations and discovery. These changes impact core depositions, expert reports, and trial preparation ahead of the first bellwether cases in 2025.

Key updates to the schedule include:

• The core depositions, originally scheduled to conclude by June 30, 2024, have been extended to August 29, 2024, to allow additional testimony.
• The plaintiffs’ expert reports, due September 30, 2024, are now scheduled for November 29, 2024, to incorporate new findings on implant degradation.
• Defendants’ expert reports have been pushed from November 30, 2024, to January 29, 2025, giving Exactech’s legal team time to challenge the plaintiffs’ claims.
• Rebuttal expert testimony will be submitted by February 13, 2025, rather than the original December 15, 2024 deadline.
• Depositions of plaintiffs’ experts will begin March 17, 2025, while defense expert depositions will be completed by April 16, 2025.
• Pretrial motions, including those excluding certain expert witnesses, must be filed by April 29, 2025, two months after the original February deadline.
• Final replies to motions will be submitted by June 10, 2025, wrapping up pretrial preparations before the first trial.

With these scheduling adjustments, both sides have more time to present medical evidence, depose key witnesses, and refine their legal strategies before trial.

New Plaintiff Joins Exactech MDL After Premature Implant Failure

A recent Exactech knee replacement lawsuit was filed in the Exactech implant recall MDL on July 9, 2024, by a man from Idaho who experienced implant failure just two years after knee replacement.  

• The plaintiff underwent total knee replacement surgery in June 2020 using an Exactech Truliant implant.
• By 2022, the polyethylene insert had deteriorated, leading to pain, swelling, and bone loss that required surgery for revision.
• Allegations of the lawsuit are that the implant’s early failure was caused by polyethylene oxidation, a known defect linked to the recalled Exactech implants.   

This case is not unusual. Exactech knee replacement devices have failed far earlier than expected, sometimes months or a few years after implantation. Lawsuits like this continue to strengthen claims against Exactech as more evidence emerges showing that improper packaging and oxidation led to severe device deterioration.

Exactech Class Action Lawsuit Update – June 2024

Slowdown in New Case Filings, but Litigation Continues

The Exactech class action MDL saw 42 cases added in June 2024. While this continues to expand the litigation, it also marks the second month in a row of declining new case filings, a sign that many affected patients have already taken legal action.

Current Case Count in the Exactech MDL

As of June 2024, there are 1,622 pending cases in the MDL: 

• 1,328 lawsuits involve Exactech knee devices  
• 277 involve Exactech hip devices 
• 10 involve ankle replacement implant systems
• 6 cases do not specify the implant type  

In addition to these federal cases, 595 lawsuits filed in Florida state court in Alachua County’s consolidated proceedings are pending.

• 417 involve Exactech knee devices  
• 170 involve hip devices
• 7 involve ankle implant  
• 1 case does not specify the implant type 

Other state court lawsuits are still being coordinated, including 24 cases in Illinois and 28 more pending across various states.

Settlement Talks Are Gaining Momentum 

One of the biggest questions for plaintiffs is whether the Exactech cases will settle before trial. The litigation is moving in that direction, as Exactech lawyers from both sides have decided to use a retired magistrate judge as a mediator to explore potential settlement options.

Several formal settlement meetings have already taken place, with offers and counteroffers exchanged. While no final settlement agreement has been reached yet, the fact that both sides are engaged in serious discussions indicates that progress is being made.

Now is the time to act for those who haven’t filed a claim. Once settlements are reached, late filers may have fewer options for compensation.

Exactech Class Action Update – May 2024

New Cases Added, but at a Slower Pace

Only 61 more cases were filed in the Exactech implant recall MDL in May 2024, marking a significant drop from the prior month. The total number of lawsuits in the Exactech class action MDL now stands at 1,462.

Fourth Bellwether Trial Selection: David Caputo’s Case 

Attorneys from plaintiffs as well as Exactech have proposed a fourth bellwether case for trial:

• David Caputo (Case No. 1:23-cv-01896), a Texas resident, had an Exactech Optetrak knee replacement in August 2016.
• By 2022, the implant had failed due to premature polyethylene wear, requiring revision knee replacement surgery.

Caputo’s case joins the previously selected bellwether cases, which will serve as test trials to determine the potential settlement value of all lawsuits. 

Exactech Class Action Update – April 2024

Bellwether Trial Schedule Finalized

On April 23, 2024, the court issued an order setting official trial dates for the first bellwether cases in the Exactech MDL:

• Tarloff v. Exactech (Case No. 23-CV-5793, EDNY Pool) – June 2025
• Larson v. Exactech (Case No. 22-CV-6643, EDNY Pool) – August 2025
• Kramer v. Exactech (Case No. 23-CV-658, National Pool) – Trial 3, TBD 2025
• Trial 4 – To be selected from the National Preliminary Pool by May 3, 2024

Spotlight on the First Bellwether Case: Tarloff v. Exactech

• Plaintiff Gayle Tarloff, a New York resident, underwent knee replacement surgery in 2016 using an Optetrak Logic implant.
• By 2023, she required surgery for revision due to extreme pain, stiffness, and implant loosening.
• Her case will be the first test trial in the Exactech MDL, making it a key indicator of how juries may respond to these claims.

Exactech Class Action MDL Growth Continues

In April, 147 more cases became part of the Exactech class action, bringing the total to 1,401 pending cases – the most significant monthly increase since mid-2023.

Exactech Class Action Update – March 2024

Unable to Hold Private Equity Firm TPG Inc. Liable – Claims Are Dismissed

A major legal decision was handed down in March 2024, as the court dismissed claims against Exactech’s private equity owner, TPG Inc.

• The plaintiffs argued that TPG controlled Exactech’s business decisions and should share liability for the defective implants.
• The court decided that TPG’s influence did not amount to direct control, leading to dismissing all claims against the private equity firm.
• While this ruling does not impact Exactech’s liability, it does eliminate a potential deep-pocketed defendant from contributing to settlements.

Increase in Case Volume

March had 75 cases join the Exactech class action MDL, bringing the total number of lawsuits to 1,244.

Settlement Talks Are Heating Up

With bellwether trials approaching, Exactech’s legal team has expressed interest in settlement discussions.

• The company requested a private meeting with judges to discuss potential global mediation.
• Exactech also asked the court to pause specific deadlines to allow negotiations to move forward.
• Some plaintiffs’ attorneys have opposed delaying the litigation, preferring to continue toward trial to strengthen their negotiating position.

Plaintiffs who have yet to file may run out of time, as a settlement could limit future claims.

Exactech Class Action Update – February 2024

Bellwether Selection Delayed as Litigation Progresses

The Exactech MDL continues moving forward, but attorneys on both sides have agreed that they need more time to finalize the bellwether case selection process. The court has approved an adjusted timeline for a more thorough review of eligible cases.

Key deadline extensions include:

• Deciding whether Lexecon will be waived was postponed. Originally scheduled for February 26, 2024, it will now be held on March 11, 2024.
• The EDNY Preliminary Pool and National Pool strike deadline has been extended from March 1, 2024, to March 15, 2024.
• The final deadline for strikes within the National Preliminary Pool is approaching but has been pushed back. Instead of March 15, 2024, it is now April 2, 2024.

These changes provide additional time for case evaluations and ensure that only the most substantial cases move forward as bellwether trials. This will help determine potential settlement values for all Exactech hip, knee, and ankle lawsuits.

Exactech Class Action Update – January 2024

Case Filings Slow as Exactech Class Action MDL Grows to Over 1,090 Lawsuits

The Exactech class action MDL now has 1,090 pending cases, but only two new cases were filed last month. This slowdown in filings was not unique to Exactech, as most mass tort MDLs saw limited growth during this period.

More specific case data reveals that:

• One thousand one hundred fifty-one cases are active in the Exactech class action MDL, mostly involving Exactech knee replacement lawsuits. 
• Three hundred sixty-eight lawsuits are pending in Florida state court, with an additional 17 cases in Illinois currently subject to a motion for coordination. 

All parties involved in the litigation have agreed that coordinating discovery between federal and state cases is essential, ensuring all plaintiffs are able to access essential evidence and expert testimony.

Exactech Pushes for Trial Delays

Exactech’s legal team has proposed adding up to four months – and maybe more – between the date expert discovery ends and the date the first bellwether trial begins. Their goal is to address:

• Rule 702 briefing to determine whether certain expert witnesses and their testimony will be admissible.
• Motions in limine, which are legal motions to exclude certain pieces of evidence from trial.

Plaintiffs’ attorneys have not agreed to these delays and argue that keeping the current trial schedule on track is in the best interest of affected patients.

Exactech Class Action Lawsuit Update – December 2023

Bellwether Trial Pool Finalized in Florida State Court

A preliminary pool of bellwether cases for the Florida state court proceedings was finalized in December 2023. The date the selection will be made was set for December 29, 2023, with both sides exchanging lists of potential cases.

MDL Case Numbers Continue to Rise

The Exactech class action saw a significant jump in case filings, with almost 200 more lawsuits added in the last 30 days. This brings the total number of federal cases in the MDL to 1,088.

New Evidence Emerges Supporting Plaintiffs’ Claims

Discovery in the Exactech implant MDL continues to uncover critical evidence. Dr. Christopher Hutchins, a Connecticut orthopedic surgeon who has performed more than 350 knee replacement surgeries using Exactech implants, testified that:

• Some Optetrak finned knee implants began to get loose within two or three years, far earlier than expected.
• This failure rate is “awfully premature” and “extraordinary”, suggesting that Exactech devices are inherently defective.
• During a 2006 or 2007 meeting with the co-founder of Exactech, Bill Petty, Petty acknowledged problems with the device, reinforcing allegations that Exactech knew about these defects long before issuing the recall. 

With this new testimony, plaintiffs’ attorneys believe Exactech’s liability is increasingly difficult to dispute.

Upcoming Status Conference

A status conference was scheduled for December 20, 2023, before Exactech MDL Judge Nicholas Garaufis and Magistrate Judge Marcia M. Henry. Key topics included:

• Reviewing the Case Management Order for The Selection of Bellwether Trials.
• Determining potential trial dates for initial bellwether cases.

Exactech Class Action Lawsuit Update – November 2023

New Cases Added, Expanding the MDL

Another 40 lawsuits became part of the Exactech MDL, increasing the total to 882 active cases in federal court. Additional cases remain pending in Florida state courts, which continue to see a high volume of new filings.

Court Issues Rulings on Key Evidence Handling Procedures

An amended Case Management Order (CMO No. 3) was issued by the magistrate judge, which provides strict protocols for handling pathology specimens and explanted Exactech devices. The order includes:

• Chain-of-custody requirements for preserving explanted implants in their original condition.
• Third-party medical storage providers responsible for maintaining evidence integrity.
• A ban on destructive testing without agreement from both parties.
• A provision ensuring that all explanted implants remain the property of the plaintiff.

Exactech Attempts to Reverse Discovery Ruling

In an unusual move, Exactech’s legal team filed a motion requesting the Exactech MDL judge to withdraw a prior discovery order.

• On October 12, 2023, the court had ruled that Exactech wrongfully withheld 35,000 internal documents.
• Exactech has since produced those documents but is asking the Exactech MDL judge to remove his prior finding, arguing that the ruling is being used against them in state court cases.
• Plaintiffs’ attorneys argue that Exactech is attempting to rewrite the record rather than take accountability for withholding critical evidence.

Key Takeaways from Recent Exactech Lawsuit Updates

• Bellwether case selection is taking longer than expected, with new deadlines set for early 2024.
• MDL cases now exceed 1,100, with hundreds of additional lawsuits pending in state courts.
• New testimony from a leading orthopedic surgeon strengthens plaintiffs’ claims, showing Exactech knew about implant failures years before the recall.
• Discovery disputes continue, with Exactech attempting to reverse a prior court ruling that found they had withheld critical evidence.

With trial dates approaching and settlement talks likely in 2024, plaintiffs should ensure their Exactech lawsuits filed are done so in time to be included in any potential global settlement. 

Exactech Class Action Lawsuit Update – October 2023

MDL Expansion and Ongoing Discovery Disputes

The Exactech class action MDL continues to grow, with almost 200 more lawsuits added over the past month. The total number of pending cases has reached 850, with additional cases still filed in Florida state court.

A recent status report filed with the court provides further case breakdowns:

• 984 total cases in the MDL
  • 811 cases involve knee devices
  • 164 cases involve hip devices 
• 327 cases are pending in state courts in Florida, with a similar knee-to-hip ratio

Despite this growth, many plaintiffs are frustrated with the litigation’s slow progress. The next major event in the MDL is scheduled for December 20, 2023, but it will be a conference with the Magistrate Judge rather than the MDL Judge, delaying key rulings and case management decisions. 

Exactech Fights Discovery Requests

A dispute related to discovery has come up in the Exactech MDL, with the company refusing to turn over key documents requested by plaintiffs’ attorneys. This occurred because Exactech has declined to provide:

1. Foreign regulatory documents related to recalls and other regulatory actions in Europe.
2. Records from other litigations against Exactech that involve similar claims of implant failures.
3. Documents from its prior merger with TPG Capital, which could shed light on financial decisions surrounding the recall.

Exactech argues that the documents are irrelevant to the current litigation. Still, plaintiffs contend they contain crucial evidence regarding what Exactech knew about its defective implants and when it knew it.

If Exactech withholds these documents, a motion to compel may be filed, leading to further court intervention.

Exactech Class Action Lawsuit Update – September 2023

Whistleblower Lawsuit Alleges Fraud Against Medicare and VA

A whistleblower lawsuit was filed against Exactech, claiming that the company knowingly supplied defective Exactech knee implants to patients covered by Medicare, Medicaid, and the Department of Veterans Affairs. 

The court determined that:

• Had the government been aware of Exactech’s high device failure rate, the government never would have paid for these implants.
• Exactech may have failed to tell the FDA about growing evidence of implant defects, further violating federal regulations.
• The lawsuit raises questions about Exactech’s compliance with the False Claims Act, a law designed to prevent fraudulent claims against government programs.

Exactech attempted to dismiss the case, arguing that the U.S. President is the only person authorized to conduct litigation on behalf of the government. However, the government countered that whistleblower provisions under the False Claims Act do not violate the U.S. Constitution.

While this lawsuit is separate from the Exactech product liability claims, it underscores broader allegations that Exactech concealed defects in its knee replacement devices for years.

MDL Growth Surges Over the Summer

Since Memorial Day 2023, the Exactech class action MDL has increased significantly – it has more than doubled:

• In May 2023, there were fewer than 300 cases.
• By September 2023, there were 658 active lawsuits in the MDL, and new cases continue to be filed monthly.

Bellwether Trial Planning Continues

Attorneys for both plaintiffs and defendants submitted a joint proposal for how bellwether trials should proceed, with a focus on:  

• Coordinating trial dates between federal MDL cases and Florida state court cases.
• Ensuring that the MDL primarily handles knee implant cases, while Florida state court trials focus on hip devices.   

The MDL judge denied an earlier bellwether plan, expressing concerns about potential delays. However, both sides’ attorneys have continued refining their approach to avoid unnecessary slowdowns.

A joint status conference will be scheduled to finalize the bellwether trial process in the coming months.

Exactech Class Action Update – August 2023

Court Orders Exactech to Produce Key Internal Documents

Responding to plaintiffs’ discovery requests, the Exactech MDL judge granted a motion to compel Exactech to turn over previously withheld internal documents. 

• Plaintiffs had requested access to internal emails, research, and testing records related to Exactech’s knee and hip implants. 
• Exactech initially refused, calling the requests overly broad and burdensome.
• The court ultimately sided with plaintiffs, ordering Exactech to provide 123,321 documents, as they fall within the revised discovery terms.

This ruling is a significant victory for plaintiffs, as these documents may provide key evidence regarding what Exactech knew about implant defects before the recall.

MDL Case Count Continues Rapid Growth

The latest Judicial Panel on Multidistrict Litigation (JPML) report confirmed that the Exactech class action MDL had 567 active cases, dramatically increasing from the prior month’s 395 cases.

Notably, cases in state courts are also expanding:

• Florida state courts now have 272 active Exactech cases, primarily filed in the jurisdiction where Exactech is headquartered.
• Additional claims are pending in Illinois and other states, signaling that litigation remains active outside the federal MDL process. 

Exactech Class Action Update – July 2023

New Case Filings Slow Down Over the Summer

Only four more cases became part of the MDL in July, marking the lowest monthly increase since the litigation began.

Legal experts believe this slowdown is seasonal rather than a decline in interest. Many plaintiffs’ firms are gearing up for an expected increase in filings later in the year.

Hearing Held on MDL Developments

Magistrate Judge Marcia M. Henry presided over a hearing in late July, though no significant case developments were announced.

Third-Party Payer Lawsuit Dismissed

The MDL judge dismissed a lawsuit filed by insurance companies and third-party payers seeking reimbursement for Exactech implant failures.

• The court stated that the plaintiffs failed to show immediate financial harm or increased costs tied directly to defective implants.
• The dismissal was without prejudice, meaning the case could be re-filed with additional evidence.

While this ruling does not impact individual patient lawsuits, it removes one avenue of financial recovery for insurers and other payers who covered implant-related medical expenses.

Exactech Class Action Lawsuit Update – June 2023

Continued Growth in MDL as Lawsuits Mount

The Exactech class action MDL continues to expand, with 12 additional recall lawsuits filed over the past month. Pending federal cases have reached 136, while another 90 cases are active in state courts in Florida.

New Lawsuit Highlights Severe Implant Failure

One of the latest filings, Nazario v. Exactech Inc. (Case No. 1:23-cv-03998), was officially added to the MDL on May 31, 2023.

• The plaintiff resides in New York and had Exactech Optetrak knee replacement in November 2011.
• The device failed prematurely, leading to severe pain, swelling, and loss of motion.
• After enduring years of complications, Nazario underwent surgery for revision in February 2022 to remove and replace the defective implant.

This case underscores the standard issue at the heart of the litigation: polyethylene liner degradation leads to early implant failure.

Exactech Class Action Update – May 2023

Surge in New Case Filings

The MDL experienced another significant wave of lawsuits, with over 80 new cases added in May. This follows a spike of 90+ cases the previous month, pushing the total MDL case count to 373.

Discovery Process Delays Frustrate Plaintiffs

Attorneys representing injured patients continue to express frustration over the slow pace of pretrial discovery.

• In January 2023, six key custodians were identified for document production.
• By February 3, 2023, Exactech’s attorneys had still not provided updates on the document collection progress.
• After multiple discussions, Exactech eventually agreed to expand the list to 12 custodians, but document production remains incomplete.

This delay has significantly slowed progress toward the first bellwether trials, leaving many plaintiffs waiting for their day in court.

Court Issues Order to Preserve Medical Evidence

A new Case Management Order was issued by the MDL judge, mandating that:

• All explanted Exactech devices must be preserved as evidence.
• Pathology samples related to implant failures must be stored with a third-party medical storage provider.
• These materials cannot be altered or destroyed before agreement on testing procedures.

This order ensures that critical medical evidence remains intact, preventing Exactech from disputing claims based on a lack of preserved materials.

Exactech Class Action Update – April 2023

Legal Battle Over Private Equity Involvement

Plaintiffs’ attorneys attempted to expand liability in the lawsuit by naming TPG Inc., the private equity firm that acquired Exactech, as a defendant.

Their legal argument focused on piercing the corporate veil, alleging that:

1. TPG had complete control over Exactech’s operations, making it responsible for product failures and recalls.
2. The corporate structure of Exactech was designed to shield liability, constituting a fraudulent arrangement.
3. TPG used Exactech as a financial tool, prioritizing profits over patient safety.

TPG countered that:

• Plaintiffs misrepresented the corporate structure, ignoring intermediary parties between Exactech and TPG.
• There was no direct evidence that TPG exercised the level of control required for liability.
• The lawsuit could set a dangerous precedent affecting private equity investment in healthcare.

While the court has not yet ruled on this motion, plaintiffs’ attorneys believe holding TPG accountable would increase the likelihood of securing a substantial settlement.

Litigation Growth Accelerates

April saw the most significant monthly case increase from the time the litigation began. One hundred eleven new cases were added, bringing the number to 290 pending lawsuits.

Exactech Class Action Update – March 2023

MDL Case Volume Jumps Again

With 47 new lawsuits added, March marked a 20% increase in total MDL case count, bringing the number of active cases to 179.

Exactech Class Action Update – February 2023 

Court Schedules “Science Day” for Expert Testimony

On May 10, 2023, the MDL judge will have a Science Day. On this date, attorneys present scientific evidence related to Exactech implant failures.

This is a critical event, as it will:

• Allow the judge to review expert opinions on the polyethylene oxidation defect.
• Help determine which scientific arguments will be admissible in future trials.
• Provide insight into how Exactech’s defense team plans to challenge plaintiffs’ claims.

New Centralized Filing System Launched

The MDL court approved a direct filing system to streamline case filings. Future lawsuits will be filed directly into the MDL rather than transferred from state courts.

Additionally, the plaintiffs’ liaison counsel launched a public website, www.exactechmdlfilings.com, giving affected patients access to:

• Critical court documents and legal updates.
• Contact information for attorneys handling the litigation.

These measures ensure that new cases can be filed efficiently, avoiding administrative delays. 

Exactech Class Action Update – January 2023

MDL Formation Marks Major Step Toward Settlement

The Exactech class action was formally consolidated into an MDL in the District of New York federal court, following a request from plaintiffs’ attorneys.

Plaintiffs’ Leadership Committee Appointed

In December 2022, the litigation judge appointed 27 attorneys to lead the case.

• The leadership includes an Executive Committee, a Steering Committee, Lead Counsel, and Liaison Counsel.
• These attorneys will oversee discovery, trial strategy, and potential settlement negotiations.

State Court Cases in Florida Also Moving Forward

While the MDL is centralized in federal court, there are also 86 pending cases in Florida state courts.

• Plaintiffs in Florida cases will undergo coordinated discovery, ensuring that key evidence is shared between federal and state litigation.
• The first significant deposition was scheduled for February 2023. This will be Dr. Sharat Kusuma, the Chief Medical Officer of Exactech.

Exactech: A Leading Medical Device Manufacturer Facing Legal Challenges 

Overview of Exactech and Its Role in Orthopedic Surgery

Exactech is a global medical device company that specializes in joint replacement implants and surgical tools for orthopedic surgeons. The company’s products are widely used in replacement surgeries for the hip, knee, and ankle.

• Founded in 1985 by orthopedic physicians, Exactech first concentrated on developing hip replacement implants. 
• During the mid-1990s, the company branched out into the knee device market with the creation of its Optetrak knee replacement system.
• By 2017, the company had entered the foot and ankle replacement sector, further broadening its orthopedic product line.

Exactech is headquartered in Gainesville, Florida, and has international offices in eight countries. It employs over 900 people worldwide.

Exactech Recall Lawsuit: Background and Legal Issues

In 2017, Exactech was taken over by TPG Capital, a global private equity firm (formerly Texas Pacific Group).

• Plaintiffs’ attorneys attempted to hold TPG liable for Exactech’s defective implants, arguing that the private equity firm played a role in the company’s financial decisions and recall response.
• However, as detailed in the March 2024 litigation update, the court ruled against including TPG as a defendant, effectively shielding the private equity firm from legal liability.
• Despite this ruling, Exactech itself remains financially responsible for lawsuits related to its recalled implants for the knee, hip, and ankle, with available corporate funds and insurance coverage.

The Exactech implant recall lawsuit centers on claims that the company’s implants were defective due to premature wear of polyethylene components, which led to early implant failure and the need for revision surgeries. 

Exactech Optetrak Knee Implants: A History of Innovation and Controversy 

Development and FDA Clearance of Optetrak Knee Systems

The Optetrak® knee implant system was Exactech’s way into the market for knee replacements, launching in 1994. Over the years, Exactech has secured multiple 510(k) FDA clearances for different versions of the Optetrak tibial inserts and knee components, including:

• Optetrak PS
• Optetrak Hi-Flex PS
• Optetrak Finned Tibial Tray
• Optetrak Offset Tibial Tray
• Optetrak RBK Tibial Insert & Tibial Tray
• Optetrak CR Slope
• Optetrak Logic

These implants are used in total knee arthroplasty (TKA), commonly known as knee replacement surgery, which is performed to:

• Relieve serious pain caused by arthritis.
• Correct knee trauma or deformities.

The Optetrak Knee Replacement Procedure

During TKA knee replacement surgery with an Optetrak system, the surgeon follows these steps: 

1. Knee Incision & Bone Preparation
   • An incision is made over the knee and the surgeon removes diseased bone.
   • A hole is drilled into the femur to secure the femoral part of the Optetrak implant. 
2. Cementing the Femoral & Tibial Components
   • The femoral implant is secured with surgical cement.
   • The surgeon then prepares the tibia (shinbone) and secures the tibial tray using cement.
3. Implanting the Polyethylene Tibial Insert
   • The tibial insert is then implanted.
   • This polyethylene insert is supposed to absorb friction between the femoral and tibial components, allowing smooth movement.

Exactech-initiated recalls center on the tibial insert, as defects in its packaging and oxidation led to accelerated wear, early implant failure, and a growing wave of lawsuits.

Exactech’s knee implant failures have caused serious pain, instability, and the need for revision surgeries, leading thousands of affected patients to file Exactech replacement cases as part of the ongoing mass tort litigation.  

Problems with Exactech Optetrak Knee Implants

FDA 510(k) Clearance and Lack of Rigorous Testing

The Exactech Optetrak knee replacement system entered the market through the 510(k) clearance process. This abbreviated FDA approval pathway allows medical devices sold without undergoing complete clinical trials. It permits manufacturers to market new devices if they are substantially equivalent to approved devices rather than proving safety and effectiveness through comprehensive premarket testing.

While this accelerated the availability of Optetrak implants, it also meant that critical design flaws were not rigorously tested before widespread patient use.

Escalating Reports of High Failure Rates

For nearly a decade after its 1994 release, the Optetrak knee system appeared to perform within acceptable standards. However, by the early 2010s, alarming failure trends emerged, prompting concern among orthopedic professionals and implant registries worldwide.

• In 2012, a study published in Orthopedics and Traumatology pointed out the “poor results” with Optetrak knee replacements, raising concerns about a potential design defect.
• In 2016, the Australian Orthopedic Registry, one of the most respected databases tracking implant performance, found that Optetrak knee implants had failure rates significantly higher than other knee replacements:
  • 5-year failure rate: 6.6% (higher than competitors).
  • 7-year failure rate: 7.9% (worst among knee implants).
  • 10-year failure rate: 9.6%, marking it as one of the most problematic knee implants in the industry.

Exactech Knew of Growing Problems but Failed to Act

By 2012, Exactech received many complaints from U.S. surgeons and patients reporting early implant failures. Complaints were also filed in the Manufacturer and User Facility Device Experience (MAUDE) database, which tracks reports of medical device malfunctions.

Some of the most frequently reported issues included:

• Loosening of the tibial component, causing instability.
• Aseptic loosening, where the implant detaches from the bone without infection.
• Excessive polyethylene wear, leading to implant degradation.
• Pain, limited mobility, knee swelling, and instability due to loose implants.

The MAUDE database contains numerous complaints about Optetrak devices that searches often max out at 500 reports, making it impossible to see the full scope of failures.

Legal Action and Exactech’s Silent Recall

Early Lawsuits Against Exactech for Defective Optetrak Implants

Due to the extremely high rates of failure, multiple product liability lawsuits were filed by patients who suffered premature implant failure. These lawsuits claim Exactech should be held liable because:

• The Optetrak system had an inherent design defect, particularly its “finned” tibial tray, which failed to provide adequate stability.
• Exactech knew of high failure rates but did not immediately recall surgeons or patients or issue a warning.
• The company quietly altered the design rather than addressing the problem publicly.

Exactech’s Silent Recall: Quietly Phasing Out a Defective Design

Instead of issuing a formal recall when failure rates became apparent, Exactech attempted to resolve the issue discreetly:

• The company slowly phased out and got rid of the finned tibial tray design—which had been linked to premature failures—but did not alert doctors or patients to the change.
• Surgeons continued to implant the device, unaware that Exactech had internally acknowledged the failure issues.
• Even after modifying the tibial tray, failure rates remained alarmingly high, leading to continued early implant failures and revision surgeries.

Only after further investigation did Exactech discover another critical manufacturing defect that directly led to the full-scale recall of the Exactech knee replacement systems. 

The Exactech Knee Implant Recall: A Nationwide Safety Crisis

Exactech determined that the root cause of the widespread failures was not just a design flaw, but a manufacturing defect in the vacuum-seal packaging used to store the polyethylene tibial inserts.

• The packaging let too much oxygen enter, oxidizing the polyethylene components before the implant was used.
• Oxidation degraded the strength and flexibility of the polyethylene inserts.
• The degraded inserts led to excessive friction and wear, leading to rapid breakdown of the implant structure.
• Many patients experienced implant failures within just a few months or years instead of a knee replacement’s expected 15-20 year lifespan.

This preventable manufacturing error resulted in serious pain, inflammation, swelling, joint instability, and loss of mobility in affected patients. Eventually, the only solution for those experiencing failure was corrective surgery, a complex procedure that carries additional risks, extended recovery time, and potential long-term complications.

Impact of the Exactech Recall and Legal Consequences

The 510(k) FDA Approval Process and Its Role in the Recall

One of the primary problems raised in these lawsuits is the problematic nature of the 510(k) FDA clearance process, which allowed:

• The Optetrak knee system is to be sold without complete clinical trials.
• The design defect to go undetected before reaching thousands of patients.
• A lack of oversight led to manufacturing defects (such as faulty packaging) until mass failures occurred.

While the 510(k) process is designed to promote innovation, the recall exposes the risks of companies failing to adequately test and monitor their products before mass distribution. 

Legal Ramifications: Thousands of Lawsuits Against Exactech

The Exactech implant recall lawsuits focus on:    

1. Product liability claims for defective implant design and manufacturing.
2. Failure to warn patients and doctors about known risks.
3. Negligence in quality control and product safety.

As the Exactech MDL litigation progresses, plaintiffs seek compensation for medical expenses, pain and suffering, lost wages, and other damages related to premature implant failure.

Key Takeaways: The Dangers of the Exactech Optetrak Knee System

• Optetrak knee implants were cleared without rigorous FDA testing, leading to widespread failures.
• Studies in 2012 and 2016 confirmed that Optetrak implants had higher-than-average failure rates.
• Exactech received hundreds of complaints about early implant failures but delayed issuing a recall.
• The company silently altered the design of the Optetrak system to reduce failures without notifying doctors or patients.
• The 2021 Exactech recall revealed a packaging defect that caused polyethylene inserts to degrade before implantation.
• Patients affected by failed Exactech implants for knees may be eligible to file a lawsuit and seek financial compensation.  

As the Exactech MDL progresses in the Eastern District of New York, these lawsuits will determine the extent of liability and compensation available for injured patients. Before settlement negotiations conclude, those affected should consult an Exactech lawyer to explore their legal options. 

Exactech Class Action: Litigation Status and Developments 

The Exactech mass tort litigation has expanded significantly, with hundreds of lawsuits filed by patients who received recalled implants for the knee, hip, and ankle. A multidistrict litigation (MDL) was created in the U.S. District Court for the Eastern District of New York, where every federal Exactech case has been consolidated under a single judge.  

In addition to federal cases, a parallel docket of lawsuits is active in Florida state courts, given that Exactech is headquartered in Gainesville, Florida. These state court proceedings run independently from the MDL but share similar legal arguments and discovery materials.

The Role of the MDL in Exactech Lawsuits 

Victims involved in Exactech recall cases, the MDL streamlines litigation, ensuring:

• Centralized pretrial proceedings, regardless of where the original lawsuit was filed (e.g., California, Texas, Illinois).
• Uniform discovery and motions, avoiding repetitive legal battles in different jurisdictions.
• Bellwether trials (these are test cases to gauge potential settlement values).

Bellwether Trials Scheduled for 2025 

Discovery is ongoing, and bellwether trials will begin in July 2025. If there is no global settlement agreement before this date, the bellwether trials will be crucial in determining how much compensation Exactech plaintiffs may receive.

However, given that Exactech is a relatively small business with less insurance coverage, legal experts predict that a settlement may be agreed to before cases are sent back for individual trials.

Similar MDL mass torts involving medical devices have followed this pattern, in which early settlements are favored over lengthy individual trials.

Financial Concerns: Can Exactech Pay Settlements?

A key concern for plaintiffs’ attorneys is Exactech’s financial ability to compensate all affected patients fully.

• Exactech is not a large medical company, unlike giants such as Johnson & Johnson or Medtronic.
• Insurance coverage may be limited, raising concerns about whether the company can cover all claims.
• Bankruptcy fears could play a role in shaping final settlements.

By October 2024, pretrial discovery had progressed, with attorneys focusing on Exactech’s financial resources and how that may affect settlement negotiations.

While patients affected by the Exactech recall are entitled to full compensation, legal teams are working to ensure that financial limitations do not result in unfair settlements. 

Example Exactech Knee Replacement Lawsuit

Recently, an Exactech knee device recall lawsuit was filed, Hursey v. Exactech, Inc. et al. (1:22-cv-07893), which illustrates the types of claims filed against the company. 

Case Summary: Hursey v. Exactech, Inc. 

• Plaintiff: Mr. Hursey
• Implant: Exactech Truliant knee system
• Implant Surgery: July 2021
• Revision Surgery: After only one year (2022)
• Claim: Defective manufacture of the implant

One unusual aspect of this case is that Hursey’s Exactech Truliant knee implant failed within a year. Most implant failure cases involve longer timelines, with degradation over several years.

This lawsuit highlights a key issue in the litigation—oxygen exposure in Exactech’s defective packaging may have weakened components before they were implanted. As a result, some patients experienced rapid implant failure, leading to intense pain and early surgery for revision.

Compensation for Recalled Knee Implants

Medical manufacturers like Exactech must legally provide safe and defect-free products. Under product liability laws, manufacturers are strictly liable for:

• Design defects 
• Manufacturing defects
• Failure to warn risks

What Makes Exactech Legally Liable?

Exactech’s recall notice admitted that the implants had a packaging defect, which led to the premature degradation of the polyethylene inserts. This self-admission of a manufacturing defect is a significant factor in holding the company liable for injuries. 

Who Qualifies for an Exactech Lawsuit?

Anyone who had surgery after 2004 and it involved an Exactech knee replacement implant system may have a valid lawsuit if: 

1. The Exactech implant system failed prematurely.
2. The patient experienced serious pain, swelling, or limited mobility.
3. Surgery for revision was required to replace the defective implant.

Types of Compensation Available

Successful plaintiffs in an Exactech knee replacement implant system lawsuits may recover damages for: 

• Medical expenses related to implant failure and surgery for revision.
• Pain and suffering caused by the defective knee replacement.
• Lost wages if the implant failure affected the patient’s ability to work.

With bellwether trials approaching in 2025, Exactech may offer settlements before the trials begin. However, given concerns about Exactech’s ability to pay, affected patients must pursue legal claims as soon as possible to ensure they are included in future settlements. 

FAQs: Exactech Recall Lawsuits  

How do I know if I have a case?

If you received an Exactech hip, ankle, or knee implant after 2004 and have experienced pain, mobility issues, or required surgery for revision, you may be eligible to file a recall lawsuit. Even if your implant has not yet failed, you could still qualify for compensation if your device is included in the Exactech recall and experiencing early failure symptoms.   

How do I know if Exactech made my implant?

Many joint replacement surgery patients do not know which brand of implant was used in their surgery. If you had a total replacement for knee, hip, or ankle, but are unsure if Exactech made your implant, you can:  

• Contact your orthopedic surgeon and ask for implant details.
• Request a copy of your medical records from the hospital where your surgery was performed.
• Check your implant registration card to see if you received one after surgery. 

Has my Exactech implant been recalled?

Your implant is likely included in the recall if you had a replacement knee or ankle surgery after 2004. Exactech has recalled all total knee and ankle replacement systems manufactured after 2004 due to defective packaging that caused polyethylene inserts to degrade prematurely.

What should I do if my Exactech implant has been recalled?

If you have a recalled implant for a hip, knee, or ankle surgery, you should: 

1. Schedule an appointment with your doctor to discuss your health and monitor for signs of implant failure.
2. Watch for symptoms, including swelling, instability, clicking sounds, or pain in the affected joint.
3. Consider a legal consultation to determine your eligibility for compensation.

Note: While Exactech is advising doctors to monitor patients rather than immediately recommending surgery for revision, those with intense pain or mobility issues may require removal or replacement of the implant sooner rather than later.

Should I submit a reimbursement claim to Exactech?

Exactech offers limited reimbursement for out-of-pocket expenses through a third-party administrator, Broadspire. However, victims should know that:

• Submitting a claim may waive your right to file a lawsuit against Exactech.
• Compensation from a lawsuit is likely to be much higher than reimbursement from Exactech’s claims process.
• Exactech’s reimbursement offer does not fully cover damages such as pain and suffering, lost wages, or the costs of future medical care.

If you’re considering legal action, consulting an Exactech lawyer before accepting reimbursement from Exactech is best.

What are the risks of waiting to file an Exactech lawsuit?

The statute of limitations for filing a product liability claim varies by state, meaning waiting too long could bar you from seeking compensation. Additionally:

• If a global settlement is reached, you may need to have an active lawsuit filed to be included.
• Exactech filed for bankruptcy (October 2024), and available compensation may become more limited as more claims are filed.

Can I file a lawsuit if I have not needed revision surgery yet?

Yes. Even if your Exactech implant has not yet failed, you may still qualify for compensation if you:

• Experience pain, swelling, or instability that could indicate early failure.
• Have undergone medical evaluations confirming potential implant degradation.
• Have been advised by a doctor that surgery for revision may be necessary in the future.

Filing early ensures you are included in settlement negotiations rather than waiting until it is too late.

What are the estimated settlement amounts for Exactech recall lawsuits?

Our Exactech lawyers have estimated: 

• Exactech knee device lawsuits may settle for $100,000 to $200,000.
• Exactech ankle replacement lawsuits may settle for slightly higher amounts due to more severe mobility impairments.   

However, several factors may influence final settlement payouts: 

• Exactech’s financial status – Exactech filed for and declared bankruptcy in October 2024, which may affect available compensation.
• Severity of injuries – Cases requiring surgery for revision will likely receive higher payouts.
• Lost income and medical expenses – Patients with significant economic losses may receive additional compensation. 

While historical settlements in defective knee replacement implant system cases suggest strong settlement values, Exactech’s financial limitations may impact final compensation amounts.

Will Exactech lawsuits settle, or will they go to trial? 

Bellwether trials in the Exactech multidistrict litigation (MDL) are set for July 2025, but there is speculation that Exactech will settle before then.

• Most mass tort cases settle before trial to avoid legal expenses and unpredictable jury verdicts.
• If bellwether trial outcomes favor plaintiffs, Exactech could push toward a global settlement.
• However, due to bankruptcy concerns, the Exactech settlement process may take longer.

Filing a lawsuit sooner rather than later ensures you are positioned to receive compensation if a settlement is reached.

How can an Exactech lawyer help me? 

Hiring an experienced Exactech lawyer can:

• Confirm your eligibility for a lawsuit based on your implant and symptoms.
• Ensure all necessary medical records and evidence are properly gathered.
• Maximize your compensation, avoiding low-ball settlements from Exactech.
• File your case within the statute of limitations, preventing missed deadlines.

Contact an Exactech lawyer today to explore your legal options if you have a recalled implant for the knee, hip, or ankle. 

All content undergoes thorough legal review by experienced attorneys, including Jonathan Rosenfeld. With 25 years of experience in personal injury law and over 100 years of combined legal expertise within our team, we ensure that every article is legally accurate, compliant, and reflects current legal standards.