Exactech is a global medical device company headquartered in Gainsville, Florida. Since it was founded in 1985, Exactech has specialized in surgical implant systems for use in joint replacement surgeries.
In August 2021, Exactech initiated a sweeping nationwide recall of all its knee replacement and ankle replacement implant systems manufactured after 2004. The recall impacts almost 150,000 knee replacement implants in the U.S. The Exactech implant systems are used in knee replacement surgery, referred to as total knee arthroplasty (“TKA”). TKA knee replacement surgery is used to relieve severe pain associated with arthritis and is also used to correct knee trauma and deformities.
These are the recalled Exactech products:
Exactech launched the recall after learning that a defect in the vacuum-seal packaging of its knee replacement systems was causing the polyethylene insert component to oxidize before use. This process was causing the polyethylene insert to significantly degrade after packaging and lose its ability to function properly in the knee replacement system. Over time, the degraded polyethylene inserts induced excessive friction and wear. This causes the premature failure of the Exactech knee replacement systems. The result is often the need for premature revision surgery.
Patients who experienced failure of their Exactech knee replacement system due to this manufacturing defect experienced significant pain and lack of mobility in their knee. Eventually, failure of the knee replacement system requires the patient to undergo corrective revision surgery. No one who has had knee surgery wants to do it again.What Should Patients with Recalled Exactech Implants Do?
Exactech sent out a letter to doctors regarding the recall. The letter instructs surgeons to immediately stop using Exactech implants in all knee and ankle replacement surgeries. Doctors and hospitals are also instructed to return their existing inventory of recalled devices for replacement. As far as their letters go, this was a pretty honest letter. Exactech is falling on its sword and admitting the problem.
As for surgery patients who already have an Exactech knee replacement system implanted, the recall letter instructs them to consult with their doctors. Doctors are advised to maintain an index of all patients with Exactech implants and closely monitor them for signs of potential insert failure.
Exactech also provided doctors with a draft letter to send to their patients - you may have received that exact letter - explaining the basis for the Exactech recall which is not very different from what our lawyers explained above.
If you have an Exactech knee or ankle replacement implant system, signs that the implant may have failed due to the defective insert include pain and swelling, inability to bear weight on the joint, grinding in the joint, or instability in the knee or ankle. Surgeons are instructed to take X-rays when a failed implant is suspected to evaluate the status of the Exactech implant.Exactech Knee Replacement Implant Lawsuits
Medical device manufacturers like Exactech have a legal obligation to ensure that their products are safe when used for their intended purpose and free of any harmful flaws or defects. The Exactech recall notice effective admits that the Exactech knee and ankle replacement implants were defective. So holding Exactech liable for injuries and damages the result will be less of a challenge than you would ordinarily have in a typical class action lawsuit.
Anyone who had an Exactech knee replacement implanted after 2004 may be able to bring a product liability lawsuit if that implant subsequently failed and they had to undergo revision surgery. Plaintiffs who bring a successful Exactech knee recall lawsuit would be entitled to damages for (a) pain and suffering; (b) medical expenses incurred in treatment and corrective revision surgery; (c) and any lost income or wages incurred as a result of the knee implant failure.History of Problems with Exactech Knee Implants
The Exactech knee replacement system has a long history of high failure rates and other problems. Exactech has always obtained 501(k) abbreviated FDA clearance for its knee replacement systems to avoid the full FDA review and approval process. From the very beginning, Exactech was aware that its OPTETRAK knee replacement implant system had a significantly higher failure rate compared to other devices.
Reports on Exactech implants in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) indicated the devices were failing at an abnormally high rate compared to other implants. These early onset failure MAUDE reports are representative of the increased rate of incidents of which Exactech had become internally aware several years ago. There are currently so many complaints about Exactech implant devices in MAUDE that a search maxes out (at 500). So it cannot show all the Exactech complaints.
These failures prompted product liability lawsuits in 2016-2017 against Exactech by users who experienced premature implant failures. Our lawyers have gone back and read those lawsuits. The attorneys who filed those lawsuits did not understand why Exactech knees were failing. They were hovering around the problem. But these Exactech attorneys did not - because they could not - fully understand why Exactech knees were failing.
These early Exactech implant lawsuits did understand that the high failure rate of these component parts was related to the “finned” design feature that is unique to the Exactech implants. These lawsuits accused Exactech of failing to warn consumers about this risk and instead pursued a “silent” recall in which they slowly replaced the finned design without recalling them. But the Exactech recall shed light on the specific oxygenation problem that caused these component parts to wear down.
Exactech’s phasing out of the finned design failed to reduce the abnormally high failure rate on their implant systems. This eventually led them to investigate other possible flaws which led to the discovery of the defective vacuum-seal packaging that prompted the recall notice.
Exactech marketed the Optetrak as “first-in-class” and its product materials and claims that the Optetrak had excellent long-term clinical outcomes. Exactech promoted the Optetrak as a system with nearly three decades of clinical success and proven outcomes for patients because of an improved design resulting in low stress on the polyethylene insert components.
In truth, however, Optetrak has performed poorly when compared to its competitors. For example, the Australian Orthopaedic Association, a preeminent, internationally recognized orthopedic implant registry, has identified the Optetrak as an implant with a higher-than-expected rate of revision. According to the 2020 Australian National Joint Replacement Registry, the rate of revision for a total knee replacement utilizing an Optetrak far exceeds international guidelines for accepted revision rates.
Exactech was aware of the high early failure rates with the Optetrak implants from the very beginning. As early as 2012, Exactech had indisputable clinical evidence that the Optetrak knee implants were failing at a much higher rate than Exactech claimed in its marketing materials. By that time, reports of early failure and revision associated with the Optetrak implants had started to accumulate in the FDA’s MAUDE database. These adverse incident reports indicated similar reasons for premature revision with the Optetrak, all of which indicated that there was a problem with the implants.
Exactech Sales Reps Aware of Opterak Problems
The general practice at Exactech (as with most orthopedic implant manufacturers) is to have their authorized sales reps present at the time of surgery to provide implant components to the surgeon. This practice relieves the hospital of the responsibility for having on stock all potential sizes and components that may be needed in surgeries. Exactech sales reps were present for both original implant surgery and any revision surgery.
Exactech sales reps observed first-hand countless cases of premature failures of the Optetrak. They witnessed the clear evidence of premature degradation of the plastic inserts, which was often noted by the surgeons as well. Often these sales reps would take the component from the surgeon to return to the company for inspection and analysis.
The Exactech sales reps were under a duty to report these findings to the engineering and medical departments of Exactech who were under a duty to then do an investigation, analyze the removed component when available (also known as retrieval analysis), and honestly and thoroughly report such findings to the FDA and the surgeons. This did not happen. Exactech’s sales reps reported the issues to the company, but Exactech continued to promote and sell the implants without alerting surgeons, patients, or the FDA of the growing evidence that the Optetrak was prone to premature failure.
Despite being aware of the problems in 20212, Exactech never changed the labeling, marketing materials or product inserts to adequately and accurately warn patients or physicians of the associated increased risks of early failure of the Optetrak. It was not until August 2021 that Exactech finally took action by initiating a safety recall of the Optetrak and other implant systems.
Exactech May Have Intentionally Concealed Opterak Problems
There is ample evidence that Exactech and its corporate executives were well aware that the Optetrak knee implant system was defective. There is no dispute that Exactech knew that the Optetrak implants had an abnormally high rate of early failure and complication and a greater propensity to wear out prematurely compared to other implants.
All indications are that Exactech knew about the issues with the Optetrak by 2012 or 2014 at the latest. By that time, however, Exactech’s founders may have already been looking to cash out by selling the company. In 2017, it was announced that a private equity company called TPG Capital was in the process of acquiring Exactech.
TPG’s acquisition of Exactech was finalized in February 2018. TPG bought out all the outstanding shares of Exactech stock for $49.25 a share, effectively converting Exactech from a public company to a privately held company.
It was only a few years after Exactech went private through the TPG acquisition that the company finally took the long-overdue step of recall of its knee and ankle implants. Had the recall been initiated before Exactech went private, it would have had a crushing impact on their stock and possibly led to various lawsuits by shareholders.
Our lawyers do not have any reported settlements or verdicts in an Exactech knee implant lawsuit. So we can’t be certain what the possible settlement amount - or jury compensation payout - for an Exactech recall lawsuit will be. But our attorneys believe that you can estimate Exactech defective implant lawsuit settlement amounts by comparing them to other knee replacement settlements and personal injury cases involving knee injuries.
Let's start with a more conservative settlement amount estimate. The average compensation payout in knee injury tort cases is roughly $110,000. But the settlement amounts in the Exactech recall lawsuits will likely be higher. You have a medical device company that a jury will see far less favorably than the average knee injury personal injury defendant. Punitive damages will be on the table. So at a minimum, you double the expected settlement amounts in these recall cases. So let's estimate the Exactech settlement payouts at $220,000 using this method.
Our Exactech lawyers also look at other knee replacement settlements to predict average individual settlement amounts. Some other knee replacement mass tort lawsuits have settled for an average individual settlement amount of $200,000.
The liability of Exactech is pretty clear. The company practically indicts itself in its Dear Doctor letter. So liability is strong and the strong liability knee replacement lawsuits were many years ago. So inflation has to be considered in the calculation. In 2022, maybe the best estimate using this as a settlement amount marker is $300,000 for Exactech recall cases.
Example Exactech Logic Knee Implant Lawsuit
One of the first post-recall Exactech knee replacement lawsuits was filed in federal court in New York. The case, Burke v. Exactech Inc., 1:22-cv-020806 (S.D. NY), was filed on March 14, 2022. The plaintiff, James C. Burke, had the Exactech Optetrak Logic implanted in his left knee in 2013 and another one implanted in his right knee two years later. Burke’s Optetrak Logic implant only lasted a short time and the complaint claims that he suffered pain, instability, and bone loss in the years following the surgery. Eventually, Burke underwent extensive revision surgery in 2019. She hired a personal injury lawyer to bring an Exactech recall lawsuit.
The product liability claims in Burke’s Exactech lawsuit rely heavily on Exactech’s February 2022 recall announcement of all Exactech knee and ankle replacement implant systems. The Burke complaint cites the recall based on the defective packaging and premature wear of the plastic liner inserts as evidence that the Optetrak implant was defective. He claims Exactech knew about these defective inserts and negligently failed to warn doctors and patients. Burke's Exactech recall lawsuit asserts that the premature failure of his Exactech knee implants after just six years was a direct and proximate result of “accelerated polyethylene wear” in the Optetrak inserts.
The Burke complaint asserts ten separate counts. But the primary theory of tort liability in the complaint is strict liability based on a manufacturing defect. Burke is seeking compensatory damages for his medical expenses and pain, as well as punitive damages.
File Your Exactech Recall Lawsuit
If your Exactech knee replacement implant failed and you had to undergo corrective surgery, contact our legal team today at 800-553-8082 to see if you have a case. You can also get a free case evaluation online.