Exactech Knee Lawsuit Filed Over Premature Failure of Optetrak Implant

Lawsuit alleges Exactech Optetrak knee failure was caused by design defects, resulting in loosening, instability, pain and knee revision surgery.

According to allegations raised in an August 2020 product liability lawsuit, problems with the Exactech Optetrak knee replacement caused a Texas man to suffer premature failure of the implant, resulting in need for revision surgery only a few years after the device was placed in his body.

The complaint (PDF) was filed by Anthony Palumbo, Jr. in the U.S. District Court for the Northern District of Texas on August 6, indicating that the Exactech knee implant was defectively designed and unreasonably designed.

2022 Exactech Optetrak Knee Recall

In February 2022, an Exactech knee recall was issued for 147,732 implants sold since 2004, which may degrade and wear out prematurely. The recall was issued due to Exactech Optetrak knee failures that were 3 to 7 times higher than other knee replacement systems.

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Palumbo indicates he underwent total knee arthroplasty (TKA) in March 2011, at which time he was implanted with the Optetrak CR Slope and tibial tray. However, the complaint indicates the knee implant failed, which resulted in loosening, the device moving out of position, instability, limited mobility, pain and swelling.

“As a foreseeable, direct, and proximate consequence of Defendants’ actions, omissions, and misrepresentations, Plaintiff suffered a painful knee revision surgery wherein he had severe complications and was admitted to the Intensive Care Unit at Baylor University Medical Center for angioedema and was intubated – nearly dying,” the lawsuit states. “The angioedema and intubation is a direct result of Defendants’ Defective Device and the necessary revision surgery.”

The case joins a number of similar Exactech Opetetrak knee lawsuits filed throughout the federal court system, each raising similar allegations that the manufacturer knew or should have known about the risk of problems, yet continued to make and sell the device for implantation into consumers.

As early as 2012, researchers published a study in Orthopaedics and Traumatology that warned of potential failures after just 25 months. In 2016, an Australian joint registry warned of higher than usual failure rates after just three years, and tied with another implant for the worst failure rate, 6.6%, after just five years. At seven years, the Optetrak had the worst failure rate of any implant on the market in 2016, with a mean failure rate of 7.9%.

According to the complaint, problems with Exactech Optetrak knee appear to be related to the use of a finned tibial trays. Although adverse event reports have been filed with the FDA for years, lawsuits indicate that instead of issuing a warning to customers or facing the bad press of a full Exactech Optetrak recall, the manufacturer engaged in a “silent recall,” by slowly replacing the finned tibial trays with a sturdier design it calls “fit” tibial trays.


February 2022 Exactech Recall Update

This story involves an Exactech Optetrak lawsuit filed in August 2020, years before reports of problems resulted in a massive Exactech recall for 147,732 knee implants distributed throughout the United States since 2004. Defectively packaged polyethylene inserts included in the total knee replacement system may wear out and fail prematurely, resulting in the need for additional surgery.

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6 Comments

  • ScottJanuary 29, 2022 at 3:19 pm

    I had an exactech knee replacement in 2013. I had to have a total knee revision in 2021 (exactech). . Less than 3 months later the second exactech total knee revision failed. Surgery is scheduled for my 3rd knee replacement. Feb 2022. Not having another Exactech knee. I have had swelling and pain from the very first knee replacement back in 2013. We need help !

  • LindaJune 7, 2021 at 1:27 am

    I’m scheduled for the 3rd replacement with my left knee and 2nd with the right. These are all ExacTech. I cannot find an attorney. The big practices won’t touch me because it has been 4 years 6 months since my surgery. (Just outside the statutes of limitations.) The smaller practices can’t afford to take it on. I’m totally frustrated and feel violated by the whole thing. I’d love to find a case [Show More]I’m scheduled for the 3rd replacement with my left knee and 2nd with the right. These are all ExacTech. I cannot find an attorney. The big practices won’t touch me because it has been 4 years 6 months since my surgery. (Just outside the statutes of limitations.) The smaller practices can’t afford to take it on. I’m totally frustrated and feel violated by the whole thing. I’d love to find a case action lawsuit I could join. Help!

  • ThomasMay 21, 2021 at 8:15 pm

    I have just been told that I need revision surgery exactly FOUR years after surgery. Not a happy camper about this

  • PeterApril 20, 2021 at 7:43 pm

    Have suffered with Exactech knee for years just had it replaced contacted several law firms no lawyer wants to touch it company gets away scot free leaving many in swollen Pain

  • MonicaApril 10, 2021 at 5:11 pm

    This is my third knee replacement surgery... it's an Exactech...it was done in 2016... I, have been in pain everyday!!! Worst night mare ever...please help... The, one before this was an Depuy Sigma...same problems.... And no one will touch that... Lawyers only deal with the Depuy Attune....so sad because there are thousands of us in pain everyday!! I, wish someone would help us!!! Thanks Monica

  • PeterMarch 17, 2021 at 3:38 pm

    About to replace extatech knee done in 2013 been living in constant pain swollen knee

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