Exactech Recall Lawsuit

Our lawyers are handling Exactech recall lawsuits in all 50 states.

Exactech has recalled thousands of knee, hip, and ankle implants. Most patients calling our Exactech lawyers have received a letter from their doctor about the recall and want to bring a claim because they have gotten or will soon need revision surgery.

Medical device company Exactech recently announced a major recall of all its knee (and ankle and hip) replacement implant systems made after 2004. This recall came after discovering that defective packing was causing a polyethylene insert component to degrade. This packaging defect caused many Exactech knee implants to prematurely fail. This replacement failure has forced and will force many patients to undergo unnecessary corrective surgery.

Knee surgery patients who had an Exactech knee implant that failed and need revision surgery may be entitled to bring a lawsuit. Our clients are filing Exactech lawsuits seeking financial compensation for their pain and medical expenses. Because the pain and suffering and other harms victims will endure were the cause of an unnecessarily defective product.

Our law firm is currently accepting Exactech knee and ankle implant failure cases from victims who had a recalled Exactech implant system (knee or ankle) that subsequently failed, requiring revision surgery. Do not sleep on your rights. Call our lawyers at 800-553-8082. You pay no fee or cost unless you get financial compensation for the harm done to you.

Exactech Lawsuit Update: November 11, 2022

The initial status conference in the Exactech implant recall MDL in federal court will be held next week. There is already a state court version of an MDL ongoing in the Florida court system. 

The Florida state MDL is already far ahead of the federal MDL in terms of time frame, with an initial bellwether test trial set for next year. This has prompted many lawyers on both sides to urge the judge in the federal MDL to expedite the process in order to catch up. 

In a pair of letters to Judge Nicholas G. Garaufis, separate plaintiffs’ Exactech attorneys have asked that he immediately permit direct filings in the federal MDL and to name lawyers to the plaintiffs’ leadership committee.  

Exactech Lawsuit Update: November 8, 2022

The Exactech implant recall lawsuits in the federal court system were recently consolidated into a new class action MDL. Meanwhile,  50 Exactech lawsuits involving recalled hip and ankle implants have been filed in Florida state courts and consolidated into a state version of an MDL class action.  

An Exactech lawsuit in state court may go to trial before the federal class action.  The judge presiding over the consolidated Exactech state court suits in Florida issued an Order scheduling the first trial for November 2023. This trial will function just like a de facto bellwether test trials for all Exactech lawsuits.

The JPML has officially consolidated the Exactech joint replacement recall lawsuits into a new class action MDL. All lawsuits involving the recalled Exactech knee replacement or ankle replacement implant systems will now be centralized in the Eastern District of New York. 

The MDL has been assigned to Judge Nicholas G. Garaufis. Judge Garaufis is a Senior Judge who was appointed to the bench in 2000 by President Clinton. 

Exactech was not opposed to the consolidation, but the joint replacement company had been pushing for the MDL to be created in the Northern District of Florida where its headquarters is located. The Exactech recall cases will now proceed through a consolidated discovery process overseen by Judge Garafis. 

With a new class action MDL on the horizon, the pace of new Exactech implant recall lawsuits has started to rapidly accelerate. Since June 1st, a total of 75 new recall lawsuits have been filed against Exactech in federal courts. Many of these new cases are being filed by groups of multiple plaintiffs. The Eastern District of New York continues to be the most popular forum, with 75 of the new cases being filed in that venue. Our Exactech lawyers, not coincidentally, are getting many clients who had surgery at the Hospital for Special Surgery in New York City.

The U.S. Judicial Panel on Multidistrict Litigation will hear on September 29, 2022 arguments on whether to consolidate federal lawsuits alleging Exactech joint failures from manufacturing and design errors into a class action lawsuit. Certifying and MDL and bringing together all of the lawsuits is a huge step forward on the path to victims receiving fair settlement amounts for the harm that has been done to them from mistakes that led to the Exactech recall.

The Exactech recall just got bigger. Exactech was forced to expand the scope of its hip and ankle replacement implant recall. Exactech sent out a new recall notice letter to healthcare providers last week advising that the implant recall initiated back in February was being expanded to cover another 40,000 acetabular hip liner components in the company’s Connexion, Novation, and other brand implant systems.

This expanded recall comes as the JPML is pondering whether to consolidate the growing wave of Exactech implant recall lawsuits into a new class action MDL. Our lawyers struggle to envision a scenario where a new Exactech class action lawsuit is not formed. We expect the court to rule as early as this month.

Lawyers for implant manufacturer Exactech submitted a response to the recent MDL motion filed with the JPML. Exactech advised the panel that supports consolidating all Exactech implant recall lawsuits in federal court into a new MDL. Exactech also agreed with the plaintiffs' venue preference in the Eastern District of New York. This should all but guarantee that the JPML will agree to form a new Exactech class action lawsuit for these recall cases.

It has now been nearly four months since Exactech announced a sweeping recall of all its knee and ankle replacement implant systems. But the majority of patients who received the defective implants have still not received any notification about the recall.

When the recall was first initiated in February, Exactech provided orthopedic surgeons with a form letter to send out to patients notifying them about the recall. Beyond providing this sample patient letter, however, Exactech has taken no further efforts to reach out to patients. There are an estimated 150,000 patients with defective Exactech implants and only a very small percentage of them have been notified of the recall.

So there is no Exactech class action lawsuit and the pace of new recall claim lawsuits remains comparatively slow. A total of nine new product liability lawsuits were filed against Exactech in federal courts during May. Only nine Exactech recall cases were filed in April.

The Exactech recall covered an estimated 150,000 patients. But a large percentage of these patients remain entirely unaware of the recall because Exactech has left it up to individual doctors’ offices to send out notification letters to patients. Look for a significant uptick in the number of Exactech recall lawsuits getting filed by the end of the summer.

This slow pace is delaying the inevitable Exactech class action lawsuit to deal with all of these lawsuits together. Exactech lawyers were waiting until there are enough lawsuits filed to go to the MDL Panel and seek a class action.

Late last month (June 2022), a group of Exactech knee implant recall plaintiffs filed a motion with the Judicial Panel on Multidistrict Litigation (JPML) for a new MDL Exactech class action lawsuit to be established for the consolidated handling of all future Exactech recall lawsuits.

The Exactech recall announcement in February has led to a steady stream of product liability lawsuits by patients who had defective knee and ankle replacements implanted. According to the motion filed with the JPML, there are currently 27 Exactech implant recall cases pending in 11 different federal districts. The motion suggests the Eastern District of New York as a possible venue for the Exactech class action lawsuit, but Exactech will most likely request the Northern District of Florida where its headquarters is located.

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 knees. 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.

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.

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 effectively 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.

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. This 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 knee replacement 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 hip recall lawsuits

Exactech repeatedly obtained 501(k) clearance from the FDA for its Optetrak, Optetrak Logic, and Truliant total knee replacement implant systems and components between 1994 and 2017.

This 501(k) clearance from the FDA is called “fast-track” approval because it does not require the manufacturer to prove the safety and effectiveness of a product. This path, also called "premarket notification", of 510(k) clearance only requires the manufacturer to explain the device’s substantial equivalence to a pre-MDA predicate device.

The FDA may then “clear” the new device for sale in the United States. All the component parts comprising Plaintiff’s Optetrak Device were cleared for marketing by the FDA under the 510(k) process or were marketed without receiving either 510(k) clearance or full approval by the FDA.

The big loophole that was created for 510(k) is that the device maker can provide proof that the not fully tested device is “substantially equivalent” to a predicate device that has been on the market for years. So full testing is not required. Product liability lawyers often see lawsuits involving these 510(k) products because - big surprise! - medical devices that are not fully tested are more like to have defects.

Exactech’s leading knee replacement implant is the Optetrak Total Knee System. In the first three months of the recall, more than half the calls from victims our Exactech lawyers have had involved Opterak. So we will focus a bit on Opterak for a moment although most of what our attorneys say about the merits of the Operterk claims apply to all Exactech lawsuits.

The Opterak is classified as a knee joint patellofemorotibial semi-constrained cemented prosthesis. It features a mix of polyethylene and metal-based components. The Optetrak is comprised of the following parts: a patellar cap, femoral cap, tibial insert, and tibial tray, as we show above. The patellar cap and tibial insert are made of polyethylene.

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.

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 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.

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 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.

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.

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.