Exactech Recalled Knee Replacements Degraded Prematurely and Failed, Lawsuit Alleges

A New York man indicates in a recently filed lawsuit that manufacturing defects caused an Exactech recalled knee replacement to fail, after a plastic insert included with the system was exposed to oxygen and degraded prematurely, resulting in the need for revision surgery.

The complaint (PDF) was filed late last week by Charles Cuneo and his wife, Joanne, in the U.S. District Court for the Eastern District of New York, pursuing claims against his knee replacement manufacturer Exactech, Inc., as the defendant.

In February 2022, Exactech recalled more than 140,000 Optetrak, Optetrak Logic and Truliant knee replacement systems that had been implanted in patients since 2004. At that time, the manufacturer warned that polyethylene inserts included with the knee implants were packaged in “out-of-specification” vacuum bags, which exposed the plastic components to oxygen before surgery and may cause premature failure once the knee replacement is in the body.

According to the lawsuit, Cuneo underwent bilateral total knee replacement in December 2013, at which time surgeons used Exactech Optetrack knee replacement systems in both knees, which included the Optetrak Logic Tibial Insert.

Although knee replacements are expected to last 15 to 20 years, a magnetic resonance imaging (MRI) scan earlier this year revealed that Cuneo was suffering from bone loss, inflammation and there was debris at the sites which was consistent with wear and degradation of the tibial insert. He was informed in March 2022 that his knee implants had failed, requiring revision surgery in May.

As a result of the Exactech knee replacement degrading prematurely, Cuneo was diagnosed with polyethylene wear, bone loss, osteolysis and component loosening. At the time the complaint was filed, he was still waiting to undergo replacement surgery for his left knee as well.

“Defendants, through their affirmative misrepresentations and omissions, actively concealed from Plaintiff and Plaintiff’s health care providers the true and significant risks associated with the Optetrak Device and the need to vigilantly do diagnostic procedures to promptly diagnose the insidious process of the toxic polyethylene particles degrading and causing osteolysis,” Cuneo’s lawsuit states. “Defendants know that after the one-year checkup following a total knee arthroplasty, typically patients are not expected to return for monitoring absent problems. Thus, Defendants knew that unless they informed surgeons to call their patients back for periodic radiologic monitoring that polyethylene chemical degradation and attendant osteolysis could be occurring unchecked until it reached the stage of severe bone loss.”

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.