Exactech Faces Lawsuit Over Catastrophic Optetrak Knee Replacement Failure, Which May Result in Partial Leg Amputation

Less than two years after the Exactech knee replacement failed, more than 140,000 implants were recalled by the manufacturer due to packaging defects

A Colorado man has filed a product liability lawsuit after experiencing the catastrophic failure of an Exactech Optetrak knee replacement, which contained a defective component that wore out and resulted in the need for revision surgery only a few years after the implant was placed in his body.

Daniel E. Carson filed the complaint (PDF) in the U.S. District Court for the District of Colorado on April 15, indicating that he may now require a partial leg amputation due to complications caused by a defective and unreasonably dangerous knee replacement system, which manufacturer has now recalled.

Carson underwent a left knee replacement surgery in December 2014, involving an Exactech Optetrak knee system. However, the lawsuit indicates that the artificial knee failed suddenly in July 2020, when the polyethylene liner degraded and caused bone loss, osteolysis, significant debris and a grossly unstable tibia. The knee failure was so sudden and severe that Carson was immediately taken to the hospital by ambulance and underwent revision surgery the next day.

“While the July 10, 2020, revision surgery was successful, because of the damage that his left leg sustained in the failure of his Optetrak knee system, in the future Plaintiff most probably will need to have an above the knee amputation of his left leg,” Carson’s lawsuit states.

More than a year after the revision surgery, an Exactech knee recall was issued for more than 140,000 Optetrak, Optetrak Logic and Truliant implants distributed since 2004, which were packaged in “out-of-specification” vacuum bags that exposed the plastic components to oxygen before they were implanted. The manufacturer acknowledged at that time that the packaging defect increased the risk that the knee implant may degrade and fail once in the body.

Exactech Optetrak Knee Replacement Problems

The case joins a growing number of Exactech knee lawsuits now being filed by individuals who experienced problems with an Optetrak, Optetrak logic or Truliant system received in recent years, indicating that the manufacturer ignored evidence of an abysmal knee failure rates associated with the implants.

As early as 2017, lawsuits over Exactech knee implants indicated there were alarming rates of adverse event reports being submitted to the FDA, which resulted in what some said was a “silent” Exactech knee recall when the company began slowly and quietly replacing the tibial trays of some Optetrak models.

In the recall notice issued earlier this year, the manufacturer now acknowledges the foreign registries have found a higher-than-expected rate of Exactech knee failures involving the poly liner, often resulting in the need for additional surgery only a few years later.