Joint replacement surgery is supposed to restore mobility and relieve pain for years, sometimes decades.
But for tens of thousands of patients who received Exactech hip, knee, ankle, or shoulder implants between 2004 and 2022, that promise has been undermined by a defect that allowed the implants to degrade prematurely, in many cases requiring a second surgery to remove and replace the failing device.
If you’re experiencing new pain, instability, or difficulty using the joint after receiving an Exactech implant, you’re not alone. That said, the FDA has also been clear that a recall alone isn’t a reason to remove a well-functioning implant, so understanding the difference matters.
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What Is the Exactech Recall?
The recall involves polyethylene components, a medical-grade plastic that cushions the joint between metal parts, used in four types of joint replacement: knee implants from the Optetrak, Optetrak Logic, and Truliant lines and, more recently, shoulder components from the Equinoxe system.
These devices were manufactured between 2004 and August 2021, with surgeries continuing into early 2022 before the full scope of the problem became clear.
The recall unfolded in stages:
June 2021: Exactech issued an initial recall of certain Connexion GXL hip liners after reports of premature wear.
October 2021: The FDA classified the knee and ankle packaging recalls as Class II.
February 2022: Exactech expanded the recall to cover all Optetrak, Optetrak Logic, and Truliant knee implants and Vantage ankle implants packaged in the defective bags, regardless of label or shelf life.
August 2022: The hip implant recall expanded further to include all affected hip devices.
March 23, 2023: The FDA issued a safety communication reminding patients and providers about the risk, stating that oxidation “can lead to accelerated device wear/failure, and component cracking or fracture, all leading to corrective revision surgery.” The FDA has periodically updated this communication since, most recently in December 2024.
January 2024: The FDA alerted providers to the same packaging problem in Exactech’s Equinoxe shoulder system, after Exactech initially declined to recall it voluntarily.
April 2024: Exactech recalled the affected Equinoxe shoulder devices.
Company disclosures and FDA records put approximately 147,732 knee and ankle devices with affected polyethylene inserts implanted in U.S. patients, and Exactech has stated that roughly 80% of its knee and ankle devices manufactured since 2004 were packaged in the defective bags.
Across every device type, including the shoulder expansion, the total recalled population runs to more than 650,000 devices.
How Do Recalled Exactech Implants Fail in the Body?
Oxidized polyethylene starts shedding plastic debris much faster than normal joint implants do. The body recognizes this debris as foreign material and mounts a chronic inflammatory response that can trigger osteolysis, a condition where the bone surrounding the implant dissolves.
As bone loss progresses, the implant’s metal components lose their stable foundation and begin to loosen, causing pain, instability, and eventually mechanical failure. In some cases, the polyethylene component itself cracks or fractures outright.
A 2020 study in the Journal of Arthroplasty examined patients who received the Exactech Connexion GXL hip liner: of 12 patients studied, 9 required revision surgery for early liner failure and associated bone loss, at an average of just under five years after implantation.
Modern hip replacements are generally expected to last 15 to 20 years or more, so these patients lost a decade or more of expected implant life. Exactech’s own analysis reportedly confirmed a statistically significant increase in failure rates for the degraded inserts compared with properly packaged devices.
On the knee side, it’s worth noting that most Exactech knee implants don’t fail early. A large 2023 study of 7,941 Optetrak Logic knee replacements found revision-free survival of 98% at 2 years, 95% at 5 years, and 86% at 10 years.
But among the 369 knees in that same study that did require revision, the majority (209 of 369) showed a recurring pattern involving polyethylene wear, inflammation, bone loss, and component loosening, the exact pattern the packaging defect would be expected to cause.
Signs Your Exactech Implant May Be Failing Early
Some discomfort is normal during recovery from joint replacement, but the following symptoms warrant medical attention:
Persistent or worsening pain, months or years after surgery. Hip patients often describe groin or thigh pain that worsens with walking or stairs; knee and ankle patients report pain with weight-bearing activities they previously handled without trouble.
Joint instability, described as the joint “giving way,” a knee buckling unexpectedly, or an ankle that can’t support weight properly. FDA adverse event reports for Exactech knee and ankle devices specifically list instability and joint laxity as recurring problems.
Swelling, stiffness, and reduced range of motion, sometimes with warmth or fluid accumulation around the implant, or a new limp.
Difficulty with activities you’d previously regained, such as walking, gardening, or other routine activities that have become painful or impossible again.
Imaging can reveal objective signs of failure even before symptoms become severe: dark areas around the implant suggesting bone loss (osteolysis), changes in component position suggesting loosening, or thinning or visible debris suggesting excessive polyethylene wear.
In some documented cases, failure has been rapid and severe rather than gradual, underscoring that these implants don’t always fail on the slow, predictable timeline patients might expect.
A recalled implant that’s working normally generally shouldn’t be removed just because it’s on the recall list.
Can You Sue for Early Implant Failure?
Yes, potentially. Product liability law holds manufacturers responsible for producing safe medical devices and warning doctors and patients about known risks. Lawsuits against Exactech generally allege:
Defective design and manufacturing, focused on the packaging failure itself, arguing Exactech knew or should have known that oxygen exposure would degrade the polyethylene but failed to ensure proper packaging
Failure to warn, arguing that even after Exactech became aware of the packaging problem, it delayed disclosing the full scope of the risk to doctors and patients
These theories translate into real, recoverable damages, including:
Medical expenses for revision surgery, including hospital bills, surgeon fees, anesthesia, physical therapy, and medication
Lost wages from time off work for surgery and recovery
Future medical costs, since revision implants often don’t last as long as a primary joint replacement, raising the possibility of yet another future surgery
Pain and suffering, including the physical toll of a second major surgery and the diminished quality of life from having to relearn a procedure you thought was already behind you
Does Early Implant Failure Mean You Need Revision Surgery?
The answer depends on several medical factors. Revision is generally recommended when:
Symptomatic loosening or instability is present. Continuing to walk on a loose implant risks further bone loss, which makes eventual revision more complex and less likely to succeed the longer it’s delayed.
Catastrophic wear or fracture of the polyethylene component is visible on imaging. If metal components are already rubbing against each other, delaying surgery risks rapid joint destruction.
Clinically significant osteolysis is present and progressing, since the inflammatory response to polyethylene debris continues as long as the degraded component remains in place.
Conservative treatment has failed. Physical therapy, activity modification, medication, or injections won’t fix a mechanically failing implant.
Monitoring instead of immediate revision may be appropriate when:
You have a recalled implant but no symptoms
A baseline X-ray shows stable components, no osteolysis, and no excessive wear
Your surgeon recommends periodic imaging, often every six months to a year, to catch any early signs of failure before significant bone loss occurs
The Exactech Litigation and Bankruptcy
Exactech joint implant lawsuits have been consolidated into federal multidistrict litigation, MDL 3044, in the U.S. District Court for the Eastern District of New York, with roughly 1,838 federal cases pending as of the most recent public reporting, plus more than 700 additional cases consolidated in Florida state court.
For New York patients, having the federal cases centered in the Eastern District means they’re being handled relatively close to home, though individual cases can eventually be sent back to their original districts for trial.
In October 2024, Exactech filed for Chapter 11 bankruptcy. That filing triggered an automatic stay that paused active lawsuits in both the MDL and Florida state court, and as of the most recent reporting available, no trials or approved settlements have occurred in the MDL.
This doesn’t eliminate anyone’s legal rights; it means the path for asserting them shifts toward the bankruptcy court framework, where Exactech and its insurers are expected to work toward a trust or settlement fund to compensate injured patients.
That process can take months or years to fully resolve, and it doesn’t change the practical steps that protect your position in the meantime.
What Should You Do If You Have a Recalled Exactech Implant?
Confirm whether your implant is affected. Contact the hospital or surgery center where your joint replacement was performed and request your implant records, including the specific manufacturer and model. Your surgeon’s office should have this in your chart, and some patients received an implant identification card at the time of surgery.
Watch for symptoms. New or worsening joint pain, instability, swelling, reduced range of motion, or difficulty with previously manageable activities shouldn’t be dismissed as normal aging.
See an orthopedic surgeon experienced in revision joint replacement, not every surgeon regularly performs complex revisions, and current X-rays compared against prior imaging can reveal loosening, osteolysis, or wear.
Ask detailed questions if revision is recommended, including why it’s necessary and what to expect; this both helps you make an informed decision and documents the medical necessity for any future claim.
Understand your monitoring plan if revision isn’t immediately recommended, including how often you’ll need imaging and what symptoms should prompt an earlier call.
Preserve all related medical records, including your original surgery, follow-up visits, imaging, any revision surgery, physical therapy notes, and medical bills.
Consult an attorney experienced in medical device litigation, even before revision surgery, to understand how the bankruptcy process affects your options and how to preserve evidence.
Frequently Asked Questions
Does the bankruptcy filing mean I can’t recover anything?
No. The bankruptcy pauses active lawsuits and shifts the process toward a bankruptcy court framework, generally involving a trust or settlement fund for injured patients, rather than eliminating anyone’s underlying legal rights. It does mean the timeline for resolution is likely to extend, which makes preserving your records and evidence now even more important.
I have a recalled implant but no symptoms. Should I still see a doctor?
Yes. A baseline evaluation and X-ray give your surgeon a reference point to detect early changes at future visits, even if immediate revision isn’t recommended. Waiting until symptoms are severe can mean more bone loss has already occurred, making an eventual revision more complex.
Does needing revision surgery automatically mean I have a legal claim?
Not automatically, but it’s a strong reason to have your situation reviewed. The recall and the FDA’s own safety communication establish that the packaging defect is a real, documented problem, but a viable claim still generally requires showing your specific device was affected and that it caused your particular injury.
What if I’m not sure which Exactech device I received?
Start with your surgeon’s office and the hospital where the surgery took place; both should have implant records identifying the manufacturer, model, and lot. If those records are hard to locate, an attorney can help identify other ways to confirm your device, though this isn’t always definitive from imaging alone.
How soon should I talk to an attorney?
As soon as possible, even if you haven’t had revision surgery yet. Understanding your rights early, and how the bankruptcy timeline affects them, helps you make informed decisions about both your medical care and your legal options, and it ensures your records and evidence are preserved while they’re easiest to obtain.
If You Have a Recalled Exactech Implant
The Exactech recall reflects a straightforward root cause, packaging that failed to protect the implant from oxidation, but the consequences for patients are anything but simple.
Whether your situation calls for immediate revision or ongoing monitoring, staying engaged with your medical care and understanding your legal options are both part of protecting yourself going forward.
Porter Law Group represents New Yorkers harmed by defective medical devices, working with experienced medical and engineering experts to evaluate each client’s case.
If you have a recalled Exactech hip, knee, or ankle implant, whether you’ve already had revision surgery or are experiencing concerning symptoms, call 833-PORTER9, email info@porterlawteam.com, or reach us through our contact page for a free, confidential consultation. Prior results do not guarantee a similar outcome.
This article is for informational and educational purposes only. It is not a substitute for medical advice from a qualified healthcare provider or legal advice based on your specific circumstances.
