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After experiencing an early knee replacement failure, an Alabama man has filed a product liability lawsuit indicating that the Exactech Optetrak implant was defectively designed and prone to experience problems with a few years after joint replacement surgery.
The complaint (PDF) was filed by Marcus Talley in the U.S. District Court for the Northern District of Alabama on October 11, indicating that the manufacturer, Exactech, Inc. knew or should have known that it’s knee implants were failing at an unreasonable rate, yet failed to warn patients or the medical community.
Talley indicates that he underwent a total knee arthroplasty, at which time an Exactech Optetrak knee was implanted in his body. However, after the knee replacement failed, Talley had to undergo risky revision surgery.
According to the lawsuit, 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, Talley indicates 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.
“Despite Defendants knowledge of early onset failures of the Optetrak knee implants and the increased risk of failure for overweight and obese patients, Defendants never alerted the FDA of the known increased risks,” the lawsuit indicates. “Reports in the Manufacturer and User Facility Device Experience (MAUDE) indicate instances of revision due to ‘loose tibial component’, ‘aseptic loosening’, ‘pain and visible loosening’, and ‘pain, limited mobility, knee swelling and sensitivity’ due to ‘loose’ joint. These early onset failure mode reports are representative of the increased rate of incidents of which Defendants had become internally aware.”
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.
The product liability lawsuit filed by Talley presents claims of negligence, violation of Alabama deceptive trade practices laws, fraudulent misrepresentation, negligent misrepresentation, fraudulent concealment, breach of warranty and fraud. He is seeking punitive and compensatory damages.