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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.
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%.
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.
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.