Exactech Knee Polyethylene Insert Degraded Prematurely and Failed, Resulting in Revision Surgery: Lawsuit

Improper packaging not only led to a massive Exactech knee polyethylene insert recall, but is also leading to cases of device failure and revision surgeries.

A product liability lawsuit claims an improperly packaged Exactech polyethylene insert degraded prematurely, resulting in early failure of a knee replacement and the need for revision surgery.

Alexander Berger and his wife, Rona, filed a complaint (PDF) in the U.S. District Court for the Eastern District of New York on May 27, alleging that an Exactech Optetrak Total Knee System was defective due to the premature failure of the polyethylene insert, which led to severe pain and the need for additional surgery to remove and replace the implant.

In February 2022, an Exactech knee recall was issued for more than 140,000 Optetrak, Optetrak Logic and Truliant implants distributed since 2004, after the manufacturer acknowledged that the polyethylene inserts were packaged in “out-of-specification” vacuum bags, which exposed the plastic components to oxygen before they were implanted. The manufacturer acknowledged at that time that the packaging defect increased the risk the knee implant may degrade and fail once in the body.

Berger underwent left total knee replacement surgery in July 2014, at which time he received the Optetrak implant. However, he was told in July 2022 that he had to undergo revision surgery, due to the failure of the polyethylene insert, bone loss, osteolysis and component loosening. The problems left him with pain and instability in his left knee.

“Thousands of patients, like Plaintiff Alexander Berger 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.”

Berger’s lawsuit indicates that the Exactech knee replacement problems have left him with daily pain and discomfort, which limit his ability to participate in activities.

Exactech Knee Replacement Lawsuits

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.

As individuals experience problems with Exactech knee inserts in the future, and knee replacement lawyers continue to investigate and claims for implant failures in recent years, the size and scope of the litigation is expected to continue to increase rapidly in the coming weeks and months.