Exactech Knee Lawsuit Filed Over Recalled Optetrak Polyethylene Liner

Recalled Exactech Optetrak Polyethylene liners have been used during knee replacements since 2004, causing premature wear and early failure

Following an Exactech knee recall issued last month, a New York woman has filed a product liability lawsuit alleging that she received one of the defective Optetrak polyethylene liners, which failed prematurely and caused her to undergo an early revision surgery.

More than 140,000 Exactech Optetrak, Optetrak Logic, Truliant and Vantage implants distributed since 2004 were impacted by the recall, after the manufacturer disclosed that “out-of-specification” vacuum bags were used with a plastic polyethylene insert component.

This defective packaging allowed oxygen to reach the plastic inserts before they were implanted, causing the component to oxidize and wear out much earlier than expected, or become damaged after it is inside in the body. As a result, thousands of individuals throughout the United States who experienced complications with their Exactech knee replacements in recent years are just now learning that their problems were caused by a manufacturing defect.

In a complaint (PDF) filed last week in the U.S. District Court for the Southern District of New York, Leslie Liberatore alleges her Exactech Optetrak knee failed seven years after it was implanted, leaving her with permanent and disabling injuries.

According to the lawsuit, Liberatore underwent bilateral total knee replacement surgery in March 2012, which included size 3.9 mm Optetrak Logic Tibial inserts made of polyethylene. However, in April 2019, she required additional revision surgery after she developed aseptic loosening and osteolysis in her left knee. She has now discovered the problems she experienced were a direct result of the defective packaging.

“As a result of Defendants’ failure to properly package the Optetrak Device prior to distribution, the polyethylene liner prematurely degraded and Plaintiff required revision surgeries due to severe pain, swelling, and instability in the knee and leg,” Liberatore’s lawsuit states. “These injuries were caused by early and preventable wear of the polyethylene insert, and resulting component loosening and/or other failures causing serious complications including tissue damage, osteolysis, permanent bone loss and other injuries.”

In the wake of the revision surgery, Liberatore says she continues to be limited in her daily activities and has difficulty getting dressed, climbing stairs, and bathing. In addition, she suffers daily pain and discomfort in her knees, impacting her quality of life, the lawsuit indicates.

Exactech Optetrak Knee 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 implant received in recent years, indicating that the manufacturer knew or should have known about the issues much earlier, given the abysmal knee failure rates associated with the implants.

As early as 2017, lawsuits over Exactech knee implants indicated that 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.

The Exactech Optetrak knee replacement system was introduced through the FDA’s controversial 510(k) fast-track approval process, meaning the manufacturer did not have to undergo extensive testing for safety and effectiveness, but only needed to show the device was “substantially equivalent” to existing devices.

The recent Exactech recall notice now suggests manufacturing changes in about 2004 caused knee replacements to be shipped with “non-conforming” vacuum bags which failed to protect the polyethylene inserts.

While Exactech has indicated it intends to cover all recall-related “out-of-pocket” expenses incurred by patients, limited information has been provided about what rights claimants may give up by seeking this limited reimbursement, when the true value of any knee replacement settlements through a personal injury lawsuit would be substantially higher.