Exactech Knee Replacement Lawsuit

Our lawyers are accepting new Exactech recall lawsuits for knee and ankle implants in all 50 states. Below we discuss the litigation, provide the most recent updates – including the bankruptcy filing – and what our lawyers believe the average per person Exactech settlement amounts will be.

On this page, you will find:

The latest news and updates on the ongoing Exatech implant litigation in federal and state courts,
How our Exactech lawyers believe these claims will unfold, and
Predicted settlement payout if this litigation is as successful as we expect.

Exactech Recall

The medical device company Exactech is one of the leading implant system manufacturers in joint replacement surgeries.

Exactech launched a sweeping recall of all knee replacement implant systems manufactured after 2004 (Exactech Recall Letter). The implants are being recalled because it was discovered that a defect in the packaging caused a polyethylene insert component to degrade before use.

The degraded inserts caused the Exactech knee implants to fail prematurely (sometimes after only a few months), causing acute pain and requiring patients to have revision surgery to replace the implant. This led to an Exactech knee replacement class action lawsuit in 2022. As we discuss below, these recall lawsuits are now pushing forward in 2024.

Filing an Exactech Lawsuit

In the last ten years, anyone who had knee replacement surgery with an Exactech implant system may be entitled to pursue a product liability lawsuit and get financial compensation for pain and suffering, medical expenses, and lost income resulting from their implant failure.

Our Exactech lawyers are actively seeking Exactech knee implant recall cases from patients adversely impacted by a defective Exactech knee implant system, including the Opetetrak® or Truliant® knee replacement systems. Contact us about filing an Exactech knee implant lawsuit.

Exactech Lawsuit Updates

Our goal is to keep you apprised of all the latest developments in the Exactech litigation:

Exactech Class Action January 2026 Update

Exactech has agreed to pay $8 million to resolve U.S. government allegations under the False Claims Act that it knowingly sold defective knee, hip, and ankle implants to Medicare, Medicaid, and the VA, even after learning as early as 2006 that some components had high failure rates. The settlement, announced shortly after approval of Exactech’s Chapter 11 bankruptcy plan, follows FDA recalls in 2021 and 2022 involving implants stored in faulty vacuum-sealed bags that allowed premature degradation and led to early device failures. This is one more piece of evidence that we were right that these were great cases, except for the bankruptcy.
Exactech filed for Chapter 11 bankruptcy after facing thousands of lawsuits over its defective knee, hip, and ankle implants. The plan, approved by a Delaware court, allows the company to restructure its debts and continue operating while setting aside money to resolve legal claims. For patients harmed by defective Exactech implants, the bankruptcy plan means their claims will likely be handled through a compensation trust or settlement fund instead of the normal court system. While this provides a guaranteed pool of money for payouts, it also caps recovery and results in smaller settlements than juries would have awarded in a trial. Victims will need to file claims through the bankruptcy process, and compensation will depend on the severity of their injuries, the strength of medical documentation, and the size of the overall settlement fund. In short, bankruptcy provides greater certainty of payment, but less than victims are entitled to or should have received.
Other that that, we are just waiting to see how this whole thing plays out. That is frustrating for lawyers so I can’t imagine how victims feel.

Exactech Class Action August 2025 Update

The revised bankruptcy plan, developed after months of litigation, now allows Exactech to sell its assets while creating a litigation trust to pursue claims on behalf of those harmed. The trust is a critical tool for unsecured creditors and tort claimants who might otherwise be left without recourse.

Claimants will soon be asked to change their votes and support the modified plan. If approved, the bankruptcy will conclude, and litigation efforts targeting TPG and related parties can move forward. The new proposal appears to offer a more equitable balance between reorganizing the company and ensuring that injured parties retain a path to recovery.

Still not sure how this will go, but the chances of more reasonable compensation for victims are higher than it was a few months ago.

Exactech Class Action June 2025 Update

Exactech is working on a revised Chapter 11 exit plan that would allow individuals harmed by its recalled joint implants to preserve their rights to pursue claims against its private equity owner, TPG. This shift comes after widespread opposition to a previous plan that would have shielded TPG from all liability in exchange for a relatively small $10 million contribution. Many viewed that proposal as an unjust attempt to insulate a deep-pocketed investor from legitimate claims involving serious medical harm.

The new approach envisions Exactech emerging from bankruptcy under the control of its senior lenders. It would also create a trust designed to handle unsecured creditor claims and potentially pursue litigation, including claims related to the defective implants. This is a meaningful development for the roughly 2,600 plaintiffs whose lawsuits were pending when Exactech filed for bankruptcy last October. Most of those plaintiffs rejected the original plan, arguing that it offered little compensation while cutting off access to a more appropriate recovery path through claims against TPG.

The proposed plan is not finalized. Lenders are being asked to contribute more to support the trust and the broader bankruptcy process, and it remains unclear whether those contributions will be sufficient. However, it is clear that plaintiffs are not backing down. Legal teams are also reevaluating previous rulings that dismissed claims against TPG, searching for new evidence or legal theories that might reopen that door.

This is not just a financial reorganization. It is a fight over accountability. Exactech is a company that distributed thousands of defective implants and now seeks protection through bankruptcy. Plaintiffs argue that its private equity owner should not be allowed to walk away with minimal consequences. The revised plan represents a small but important victory for those trying to keep the path to justice open. As the case continues, the outcome will signal how much protection bankruptcy can provide for corporate investors when real people have suffered lasting harm.

Exactech Class Action May 2025 Update

There are now 1,842 active lawsuits pending in the Exactech orthopedic implant litigation, a small drop from last month’s total of 1,851.

Exactech Class Action March 2025 Update

With the bankruptcy still pending, the automatic stay prevents any new Exactech lawsuits from being filed and added to the MDL. The number of cases in the MDL remains at 1,840.

Exactech Class Action February 2025 Update

As expected, no new cases were added to the Exactech MDL last month due to the bankruptcy stay. While our firm is not accepting new lawsuits, we remain are hopeful for favorable outcomes despite the ongoing bankruptcy proceedings.

Exactech Class Action January 2025 Update

No new cases were added to the Exactech class action MDL during December. This is the result of the automatic stay that took effect when Exactech filed for bankruptcy, which prevents new cases from being filed. The number of pending cases in the MDL sits at 1,839.

Exactech Class Action December 2024 Update

The Exactech implant recall MDL continued its steady growth with 33 new cases added in November, down slightly from 36 in October. The total now stands at 1,839 pending cases. Exactech filed bankruptcy in the first week of November, so all of these new cases were likely pending before the bankruptcy and transferred into the MDL afterwards.

Exactech Class Action November 2024 Update

The Exactech implant MDL continues to grow. Another 36 new cases were added to the MDL in October. That pushes the total number of pending cases up to 1,806. Next month will be different. When a defendant files for bankruptcy, as Exactech has, an automatic stay goes into effect. This stay halts most lawsuits and collection efforts against the defendant, asAll Posts the bankruptcy court manages all claims. This means that, in most cases, you cannot continue or initiate a lawsuit against the defendant without special permission from the court. New cases need to file a claim with the bankruptcy court
Exactech declared bankruptcy which they have been threatening to do ever since plaintiffs’ lawyers refused their ridiculous offers to settle this litigation. Plaintiffs should not panic. There is insurance and assets available to victims in bankruptcy.
The first bankruptcy hearing was on October 30, 2024.
A status conference on January 9, 2025, will provide updates on the bankruptcy and address any immediate issues, with joint status reports required every 90 days thereafter. All other case deadlines are adjourned indefinitely until the court receives further clarity from the bankruptcy proceedings
Exactech President and CEO Darin Johnson stated, “We face unsustainable liabilities associated with knee and hip litigation related to the packaging recalls we voluntarily initiated between 2021 and 2022. We take our commitment to patient well-being very seriously and have provided substantial out-of-pocket patient reimbursements and surgeon support for related expenses.” But the company also “vigorously disputes” the claims. I don’t know how to reconcile the two.

Exactech Class Action April 2023 Update

We wrote last month about plaintiffs’ efforst to impose liability on a private equity sponsor of Exactech against TPG Inc., Osteon Holdings, Inc., Osteon Merger Sub, Inc., and Osteon Intermediate Holdings II, Inc. (collectively, “TPG”). Their lawyers wrote a letter on March 30, 2023 to MDL Judge Nicholas G. Garaufis, asking for a hearing to dismiss the cases because they were not involved design, manufacture, packaging, or sale of any Exactech device.

Plaintiffs’ Exactech lawyers seek to pierce the corporate veil. To state a veil-piercing claim, a plaintiff must allege that the parent’s “exclusive domination and control to the point that the [subsidiary] no longer has legal or independent significance of its own” and “the corporate structure caused fraud or similar injustice.” The letter claims Plaintiffs have not state a veil-piercing claim for three reasons.

Firstly, defendants argue that the plaintiffs obfuscate the corporate structure to try to connect TPG to Exactech—ignoring the Osteon entities between Exactech and TPG Inc. Second, they say none of Plaintiffs’ allegations are sufficient to prove the “domination and control” required to state a veil-piercing claim. And third, Plaintiffs have not even tried to allege that Exactech “was formed or used by its corporate parents to achieve an improper purpose” or “exist[s] for no other purpose than as a vehicle for fraud.”

TPG argues that Plaintiffs’ claims were successfully asserted against it would upend the entire private equity industry (which might not exactly terrify middle America). TPG says it would be unprecedented. But TPG’s activity in the nuances of Exactech might be unprecedented, too.

Again, the whole purpose of this exercise is to make sure there is money to pay Exactech settlement amounts and jury payouts given the size of this litigation and the relative small size of Exactech.

Growing Litigation

This month, we witnessed a significant surge in new Exactech implant recall lawsuits, with 111 new cases either filed or transferred into the Exactech class action lawsuit over the past 30 days. This marks the largest monthly increase since the litigation’s inception, raising the total number of pending cases to 290. This likely signifies the beginning of an ongoing trend for the remainder of the year. Additionally, over 80 Exactech cases are pending in a Florida state court MDL.

Exactech Class Action March 2023 Update

The Exactech implant recall class action added 47 new cases over the last monthly period. That is an increase of over 20%, the biggest monthly increase since the litigation started, and it brings the total number of plaintiffs in the Exactech MDL up to 179.
Post on the effort to expand the defendants responsible for the Exactech recall
New Exactech lawsuits continue to be filed. A Maine woman filed a new lawsuit alleging that her Exactech knee device, implanted during two knee replacement surgeries in 2012, was defective and caused permanent and debilitating injuries. She underwent a right total knee replacement on January 30, 2012, and a left total knee replacement on October 1, 2012 at the St. Mary’s Regional Medical Center in Lewiston, Maine. The Exactech Knee Device implanted during the surgeries included various components such as the Exactech Tibial Insert, Tibial Tray, and Femoral Component. In 2018, she required revision surgery due to polyethylene liner wear with resulting osteolysis, aseptic loosening of the tibial component, and development of complex regional pain syndrome. She suffers daily knee pain and discomfort, gait impairment, poor balance, and difficulty walking.

Exactech Class Action February 2023 Update

On May 10, 2023, the Judge in the Exactech recall class action MDL will hold a science day during which lawyers for each side will make presentations to educate the court about the various scientific issues and evidence involved in the cases. The Exactech MDL now has 132 pending cases.
The Exactech MDL Judge recently finalized the process that allows all future Exactech implant lawsuits to be filed directly in the MDL. Plaintiffs’ Liaison Counsel also launched a new website (www.exactechmdlfilings.com) was also launched by Plaintiffs’ Liaison Counsel to give the public access to key documents relating to the litigation, such as Court Orders and attorney contact information. Judge Garaufis also has plans to hold a Science Day (we will explain Science Day in detail when the date is chosen) and has asked the parties to submit a joint proposal this week for the time frame and logistics of that event.

Exactech Class Action Lawsuit January 2023 Update

We now have a class action lawsuit pending for the Exactech recall in New York. The class action is the result of Exactech lawyers filing a motion with the JPML asking for the creation of a new Exactech class action lawsuit. This is a big step towards an eventual settlement.
In mid-December 2023, the judge in the Exactech recall MDL named 27 lawyers to the plaintiffs’ leadership committees for the litigation. There will be an Executive Committee, a Steering Committee, lead counsel, and liaison counsel. So we are now moving forward.
The class action is the result of Exactech lawyers filing a motion with the JPML asking for the creation of a new Exactech class action lawsuit. This is a big step towards an eventual settlement.
In mid-January 2023, parties for both sides in the Exactech recall MDL in federal court submitted a joint status report to Judge Garaufis before the status conference. The status report advised that the consolidated proceedings in Florida state court now have 86 pending cases, and discovery is starting to get underway. Master discovery requests were served last month, and the deposition of Exactech’s chief medical officer, Dr. Sharat Kusuma, is scheduled for February.

Exactech

Exactech is an international medical device company specializing in surgical implants used in joint replacements (e.g., knee, hip, and ankle). Exactech also makes surgical tools and technologies for orthopedic surgeons.

Exactech is headquartered in Gainesville, Florida, but it has international offices in 8 different countries, employing over 900 people worldwide. The company was originally founded in 1985 by a group of orthopedic doctors. Initially, the Exactech business was focused entirely on hip replacement implants, but in the mid-1990s, they entered the knee implant market. In 2017, Exactech began making ankle and foot replacement implants.

Exactech was acquired by TPG Capital (formerly known as Texas Pacific Group), a global private equity firm, in 2017. Plaintiffs’ lawyers had a plan to bring in TPG as a defendant. But as our lawyers explain in our March 2024 update above, that plan failed when the court rejected it. Exactech has money and insurance. TPG would have brought more of both.

Exactech Optetrak Knee Implants

Optetrak® is Exactech’s proprietary knee replacement implant system. Optetrak was first launched in 1994, and it was Exactech’s initial entry into the knee replacement implant field.

Since 1994, Exactech has repeatedly obtained 510(k) FDA clearance for various Optetrak devices and tibial inserts, including the Optetrak PS, Optetrak Hi-Flex PS, Optetrak Finned Tibial Tray, Optetrak Offset Tibial Tray, Optetrak RBK Tibial Insert, Optetrak RBK Tibial Tray, Optetrak CR Slope, and Optetrak Logic. These devices are used for knee replacement surgery, referred to as total knee arthroplasty (“TKA”). The primary indication for TKA is to relieve severe pain associated with arthritis and may also be used to correct knee trauma or minor knee deformities.

During a TKA procedure, the surgeon makes an incision over the knee and prepares the femur by removing any diseased bone and drilling a hole for the femoral component of the Optetrak implant. The Optetrak femoral implant is then fixed in place using surgical cement. Next, the surgeon performs the same preparation on the bone located at the bottom of the knee (the proximal tibia). The tibial tray of the Optetrak is then implanted using surgical cement.

Once the femoral implant and tibial tray components of the Optetrak are in the plant, a third part of the system, called the “tibial insert,” is implanted. The tibial insert is made from polyethylene and is designed to absorb friction between the two parts during movement.

Problems With Optetrak Knee Implants

The Optetrak knee implant system was approved under the abbreviated 501(k) FDA clearance process, which means it was never subject to a full FDA review and approval. The Optetrak was successful in the decade following its initial release in 1994. More recently, however, the implant system has been plagued by abnormally high failure rates.

In 2012, an article published in the journal Orthopedics and Traumatology highlighted “poor results” displayed by the Optetrak knee replacement systems and suggested it was related to a design flaw. In 2016, the Australian Registry, a preeminent, internationally recognized orthopedic implant registry, identified the Optetrak as an implant with a higher-than-expected revision rate. Specifically, the Optetrak was found to have the worst failure rates among all knee replacement implants at five years (6.6%), seven years (7.9%), and ten years (9.6%).

Exactech was aware of these abnormally high failure rates, and they were getting a flood of incoming reports about implant failures from around the U.S. beginning in 2012. Reports in the Manufacturer and User Facility Device Experience (MAUDE) indicated instances of revision due to “loose tibial component,” “aseptic loosening,” “polyethylene wear,” “pain and visible loosening,” and “pain, limited mobility, knee swelling, and sensitivity” due to a “loose” joint. These early onset failure MAUDE reports are representative of the increased rate of incidents of which Defendants had become internally aware. There are so many complaints about the Optetrak devices in MAUDE that a search maxes out (at 500) and cannot show them all.

Reports of the excessively high failure rates of the Optetrak implants sparked many product lawsuits against Exactech by patients who experienced premature implant failures. These previous Optetrak implant lawsuits alleged that the high failure rate was evidence of general design defects, including the unique “finned” design feature of the original Optetrak system.

Exactech responded to this situation by pursuing a “silent” recall in which they gradually phased out the finned design without announcing anything. This alteration to the design of the Optetrak failed to decrease the alarmingly high failure rates, which eventually led Exactech to discover the problem with the defective vacuum-seal packing, which was causing the polyethylene inserts to degrade and malfunction prematurely.

Recall of Exactech Knee Implants

In 2021, Exactech took the first steps towards a sweeping nationwide recall of all its knee replacement implant systems manufactured after 2004. The recall impacts an estimated 147,000 knee replacement implants in the U.S. The Exactech implant systems are utilized in knee replacement surgery, referred to as total knee arthroplasty (“TKA”). TKA knee replacement surgery is generally used to treat chronic pain associated with arthritis, and TKAs are also used to correct knee trauma and deformities.

Exactech has several different lines of knee replacement implant systems that are covered by the recall. These include:

Optetrak® (1994)
Optetrak Logic® (2009)
Truliant® (2017)

Exactech initiated the recall after discovering that the vacuum-seal packaging used for its knee implant systems was defective. The defective packaging allowed too much air in and caused the polyethylene insert component in the implant systems to oxidize before the product was used. The oxidation significantly degraded the polyethylene of the inserts after packaging, impairing the ability of the inserts to function correctly in the knee replacement system. Over time, the impaired polyethylene inserts caused excessive friction and wear, triggering the premature failures of the Exactech knee replacement systems.

Early failure of the Exactech knee replacement system due to this manufacturing defect can devastate patients. Implant failure causes significant pain, swelling, and lack of mobility in the knee. Eventually, patients who experience implant failures must undergo corrective revision surgery to replace the defective implant.

One of the critical issues exposed by the Exactech lawsuits is the potential shortcomings of the 510(k) process, which allows medical devices to enter the market with minimal clinical testing if they are deemed “substantially equivalent” to an already-approved device. While this pathway can expedite innovation, the Exactech debacle underscores the risks when design flaws or manufacturing defects are not adequately addressed before reaching patients.

Exactech Class Action Lawsuit

The Exactech litigation landscape has developed considerably over the past few years. A multidistrict litigation (MDL) has been established in the U.S. District Court for the Eastern District of New York, consolidating all federal Exactech implant recall lawsuits under one judge. Additionally, Florida state courts are handling a significant volume of Exactech-related cases, creating a parallel docket at the state level.

For plaintiffs involved in Exactech lawsuits, the MDL in New York means that no matter where their case was filed—whether California, Texas, Illinois, or elsewhere—all pretrial proceedings will occur under the oversight of the Eastern District of New York. This centralized process streamlines discovery, motions, and bellwether trials, which are essential in shaping the direction of settlements or trial outcomes.

Discovery is already well underway, and key bellwether trials are scheduled to begin in July 2025. If a global settlement is not reached before then, these trials will serve as critical benchmarks, influencing the potential settlement value of remaining cases. However, the dynamics of this litigation, including the fact that Exactech is a smaller company with limited insurance coverage, make it likely that a settlement will be reached before cases are remanded to their original jurisdictions for trial. This outcome aligns with trends observed in similar MDL cases, where early resolution has been a strategic priority.

In October 2024, pretrial discovery has progressing smoothly and the parties are gearing up for that first trial in July. Most of the concerns victims’ Exactech lawyers have in this litigation involve Exactech’s ability to pay full compensation to all plaintiffs. Given the company’s relatively small size and limited insurance coverage, there is some unease about whether Exactech will have the financial resources to meet the full scope of potential settlements or judgments, which could influence the final resolution strategy for these cases.

Example Exactech Knee Replacement Lawsuit

A recent Exactech knee replacement recall lawsuit is Hursey v. Exactech, Inc. et al. (1:22-cv-07893). This suit was filed in the Exactech class action MDL.

The plaintiff, Mr. Hursey, had an Exactech Truliant knee system implanted during a knee replacement surgery in July 2021. Just one year later, Hursey had to have revision surgery because the Tuliant implant had prematurely failed. His knee replacement suit asserts numerous causes of action, with the primary theory of recovery being defective manufacture.,

Interestingly, the knee system failed so quickly. The more classic cases our lawyers are seeing are that revision surgery is needed for longer. This seems more consistent with the oxygenation wearing down the component parts.

Compensation for Recalled Knee Implants

Medical device companies like Exactech are legally required to ensure their products are safe and do not harm consumers when used as intended. This responsibility makes manufacturers strictly liable for hidden design flaws or defects that cause harm. This is what we have here.

The Exactech recall pretty frankly acknowledges that the knee replacement implants had a manufacturing defect (faulty packaging). As a result, Exactech may be held liable for any injuries or damages caused by this defect.

Anyone who received an Exactech knee replacement system after 2004 may have grounds for a product liability lawsuit if the implant failed, leading to pain and revision surgery. Successful plaintiffs could recover damages for (a) pain and suffering, (b) medical expenses for treatment and revision surgery, and (c) lost income or wages due to the implant failure.

FAQs: Exactech Recall Lawsuits

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

If you have a recalled Exactech knee or ankle replacement implant, you should make an appointment with your doctor to discuss your options. Removal or replacement of the recalled implant may be necessary at some point. Still, for now, Exactech is advising doctors to maintain an index of patients with recalled implants and closely monitor them for signs of potential insert failure.

How do I know if my implant has been recalled?

If you have a knee or ankle replacement implant system made by Exactech. Your surgery occurred after 2004, then your implant is almost definitely covered by the recall. The recall covers ALL Exactech total knee replacement systems and ankle replacement systems that were manufactured at any point after 2004. This effectively covers all Exactech knee and ankle implants surgically installed in the last nine years.

How do I know if Exactech made my implant?

Many patients who have joint replacement surgery have no idea what brand of implant system they have. If you had total knee replacement surgery, but you don't know whether Exactech made your implant, you will need to ask your orthopedic doctor or request your medical records from the surgery to determine who manufactured your implant device.

As part of the recall, Exactech is inviting patients with recalled implants to submit "claims for reimbursement" and has hired a third-party administrator (Broadspire) to manage the claim process. Patients should be aware, however, that if they submit a claim for reimbursement to Exactech, they will likely waive their right to file a product liability lawsuit against Exactech for the recalled implant. Patients who submit reimbursement claims to Exactech will get far less compensation than they would otherwise be entitled to if they brought an Exactech recall lawsuit in civil court.

What do you expect for Exactech recall lawsuit settlement amounts?

Our attorneys estimate that Exactech knee replacement recall lawsuits may have a settlement value of $130,000 to $190,000 and ankle replacement recall lawsuits may have a slightly higher value. This was our prediction in 2022 and it is still our prediction in 2024.

Predictions for Exactech settlement amounts at this stage are dicey. It also does not factor the concerns that Exactech is not a huge company and it may not have enough insurance to pay full compensation for these claims. That concern has continued to rise as this litigation progresses. So take these settlement amount projections with a grain of salt. (And all of this was written before Exactech declared bankruptcy in October 2024.)

That said, there is some history to make prediction. They are based on historical settlement amounts in defective knee replacement lawsuits and the specifics of this Exactech recall. There lawsuits clearly have a great deal of jury appeal.