Exactech Optetrak Knee Failure Results in Lawsuit Over Defective Implant Design
Lawsuit alleges Exactech knee replacement is unreasonably dangerous and prone to fail within a few years, resulting in the need for additional knee surgery.
The makers of the Optetrak knee replacement system face a product liability lawsuit over design defects, which allegedly resulted in knee implant failure and the need for revision surgery.
The complaint (PDF) was filed by Diane Stanesic in the U.S. District Court for the Western District of Pennsylvania on January 9, indicating that the Exactech Optetrak knee implant was unreasonably dangerous and prone to fail within a few years, resulting in loosening and other complications.
2022 Exactech Optetrak Knee Recall
Following this lawsuit, a massive Exactech knee recall was issued in February 2022, impacting 147,732 implants sold since 2004. A defective plastic insert used in the knee replacement may degrade and wear out prematurely, causing Exactech Optetrak knee failures that are 3 to 7 times higher than other knee replacement systems.
Stanesic indicates that an Exactech Optetrak implant was used during her knee replacement surgery, causing her to experience pain and other systems long after the surgery. Due to the defective implant design, Stanesic indicates that the Exactech knee failed, resulting in the need for additional surgery to remove the implant from her body.
“The components of the device were defective, unreasonably dangerous and failed, resulting in loosening, malpositioning of the implant, and rubbing/wear of the components causing instability, limited mobility, swelling and pain,” the lawsuit states. “This was initially discovered upon revision surgery on the Plaintiff’s left knee.”
The case joins a growing number of similar lawsuits over Exactech Opetetrak knee failures, 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%.
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Design problems with several types of knee implants have resulted in lawsuits for individuals who experienced painful complications.
Learn More About this Lawsuit See If You Qualify For CompensationAccording 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.
The Optetrak knee replacement system has been on the market since 1994, with the original, and following versions, all approved through the FDA’s 510(k) approval process, meaning they did not have to undergo extensive testing for safety and effectiveness, but only needed to show they were “substantially equiavalent” to existing devices.
In 2015, Exactech pulled in about $70 million in sales from its knee implant systems.
The complaint comes as a number of similar knee replacement lawsuits have been filed over design problems associated with several different other implant systems, including the DePuy Synthes Attune knee and Arthrex IBalance knee.
February 2022 Exactech Recall Update
This story involves an Exactech Optetrak lawsuit filed in January 2018, years before Exactech recalled knee implants used in 147,732 systems 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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5 Comments
JulieFebruary 23, 2020 at 6:20 pm
I had a exactech primary total knee replacement. In 2014. In 2016 I had to have a partial revision due to extreme pain, swelling and instability. They replaced the plastic spacer with another exactech spacer accommodate the other existing components. In 2019 I was diagnosed with total knee replacement failure. I had to undergo another revision, this time a total knee complex revision, [Show More]I had a exactech primary total knee replacement. In 2014. In 2016 I had to have a partial revision due to extreme pain, swelling and instability. They replaced the plastic spacer with another exactech spacer accommodate the other existing components. In 2019 I was diagnosed with total knee replacement failure. I had to undergo another revision, this time a total knee complex revision, 4 hours in surgery and was replaced with a Zimmer biotech nexgen total knee system on 2-10-20. I had experienced pain, swelling, inability to fully bend or straighten the knee, instability and was also diagnosed with loosening of both femoral and tibial components and osteolysis, bone loss due to the inflammatory process caused by the failure of the prosthetic knee replacement in 2014.
FlorettaDecember 5, 2018 at 11:02 am
I had bilateral knee replacement in 6/2013. I had complication from day one.After being discharge I was in the doctors office every 2 to 3 weeks from excruciating pain in both knees and unable to walk properly. It wasn't until 6 months later after I lost my job and insurance that the doctor discovered that there was a problem from the procedure. I owed a bill and with no job and no insurance, no s[Show More]I had bilateral knee replacement in 6/2013. I had complication from day one.After being discharge I was in the doctors office every 2 to 3 weeks from excruciating pain in both knees and unable to walk properly. It wasn't until 6 months later after I lost my job and insurance that the doctor discovered that there was a problem from the procedure. I owed a bill and with no job and no insurance, no surgery.
RobbieSeptember 26, 2018 at 12:17 am
I have been in pain since my surgery in 2015. X-rays show that device is loose and must be replaced. It aches, I am unstable, it swells, I have pain to my ankle. Yes, I am living proof of s Exactech Optetrak PS Knee Implant gone BAD!!!!
TamathaJuly 24, 2018 at 6:08 am
Surgery12/14 removed due to it becoming unglued and then infected 8/16 a antibiotic spacer was placed. 10/17 it had to be replaced due to emergency it was pressing a nerve . I now get to choose to risk the replacement again, fuse the bones, leave it as it is, or amputate. But no matter if any one of the 3 of will mean amputation if they fail. I’ve already lost my career been forced to retire and [Show More]Surgery12/14 removed due to it becoming unglued and then infected 8/16 a antibiotic spacer was placed. 10/17 it had to be replaced due to emergency it was pressing a nerve . I now get to choose to risk the replacement again, fuse the bones, leave it as it is, or amputate. But no matter if any one of the 3 of will mean amputation if they fail. I’ve already lost my career been forced to retire and ride in a wheelchair. I don’t have much of a life left ...
JoanJanuary 19, 2018 at 6:40 pm
I made another comment on another page. I had total knee replacement surgery, both knees same day, June 1, 2007. Zimmer brand. Have never had a problem. Very happy with the results, had an awesome surgeon. I checked out the different brands, also my surgeon was a sports medicine doctor which I have been told is the best.