Exactech Knee Implant Failed After Two Years, Lawsuit Alleges

The Exactech knee implant lawsuit claims the manufacturer knew about high failure rates for years, but failed to warn patients or the medical community.

According to allegations raised in a recently filed product liability lawsuit, a recalled Exactech Knee implant failed after just two years, resulting in the need for early revision surgery and leaving an Ohio man with permanent disabilities.

Kevin McGuire filed the complaint (PDF) in the U.S. District Court for the Northern District of Ohio on August 19, pursuing claims against Exactech, Inc. for manufacturing and selling defective knee implant systems that were known to fail prematurely.

An Exactech recall was issued in February 2022, after the manufacturer acknowledged that “out-of-specification” vacuum bags were used with more than 140,000 polyethylene inserts included with Optetrak, Optetrak Logic and Truliant total knee replacement systems sold since 2004, which exposed the plastic tibial inserts to oxygen before they were implanted. Several hip and ankle implants were also recalled

McGuire indicates he received one of those defective implants and joins a growing number of individuals now pursuing an Exactech knee replacement lawsuit, alleging that their lives have been negatively effected when the implants failed prematurely, resulting in severe and permanent injuries.

According to the lawsuit, McGuire underwent right-side total knee replacement surgery in 2020, during which time he received an Exactech Optetrak knee implant. However, by April 2022 the implant had failed, requiring revision surgery to remove it. Only a few months later, Exactech recalled the knee implant used in McGuire’s surgery.

McGuire claims Exactech knew about the problems, and the risk that the knee implants fail after a few years, but failed to correct the design or warn patients.

“Despite Defendants’ claims in its promotional materials of over 30 years of successful outcomes with knee devices, Defendants knew of an unacceptably high early failure rate of its Optetrak knee implants,” the lawsuit states.

Exactech Knee Implant Problems

At least 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.