Knee Replacement Revision Caused by Failure of Recalled Exactech Optetrak System, Lawsuit Claims

Failure of an Exactech Optetrak implant resulted in the need for knee replacement revision surgery, due to defective packaging of the polyethylene insert, according to the complaint

Thousands of individuals who received recalled Exactech Optetrak knee implants have been or will be required to undergo extensive knee replacement revision surgery, according to allegations raised in a lawsuit, which indicates that defects cause the components to degrade over time, resulting in an inflammatory response, bone loss and premature failure.

The complaint (PDF) was filed by Herbert Hahn in the U.S. District Court for the Eastern District of New York on June 23, pursuing claims against Exactech, Inc. for failing to properly package it’s Optetrak knee replacement system before distribution, which allowed oxygen to reach the components before they are implanted.

In February 2022, an Exactech knee recall was issued for more than 140,000 Optetrak, Optetrak Logic and Truliant implants that had already been placed in patients since 2004, indicating that a polyethylene insert was packaged in “out-of-specification” vacuum bags, which could cause oxidation and premature failure once the knee replacement is in the body.

Hahn indicates he underwent right knee replacement surgery in 2016, at which point he was implanted with an Optetrak system. However, the lawsuit states the implant failed, and he will now require a knee replacement revision in August 2022, due to a diagnosis of polyethylene wear, bone loss, osteolysis and component loosening.

“Thousands of patients, like Plaintiff Herbert Hahn, have been, and/or will be, required to undergo extensive revision surgery to remove and replace defective Optetrak Devices due to a recent recall of these devices which first revealed to patients and surgeons that the polyethylene components within the prosthesis prematurely degrades over time causing an inflammatory response resulting in bone necrosis (death) also known as osteolysis,” the lawsuit states. “The recall notice admits that the recall and problems arose from failure to properly package the polyethylene insert component of the Optetrak Device.”

Exactech Knee Replacement Revision Lawsuits

The case joins a growing number of Exactech knee replacement lawsuits now being filed by individuals who required revision surgery after receiving 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 involving premature knee replacement revision surgery, which resulted in what some said was a “silent” Exactech 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 revision surgery caused by a degraded poly liner.

As individuals continue to experience problems and require Exactech knee replacement revision surgery in the future, it is expected that thousands of similar lawsuits will be filed throughout the U.S. Court system.