Optetrak Knee Lawsuit Filed Against Exactech Over Failure to Properly Package Polyethylene Insert

Thousands of individuals who received defective Optetrak knee replacements will likely have to undergo revision surgery as the devices fail prematurely, according allegations raised in a recently filed lawsuit against Exactech.

The complaint (PDF) was brought late last month by Domenic Dellanno and his wife, Annette, in the U.S. District Court for the Eastern District of New York, indicating that Exactech sold defective joint replacement systems, which contained improperly packaged polyethylene inserts, which are now failing 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, which exposed the plastic tibial inserts to oxygen before they were implanted. Several hip and ankle implants were also recalled

Dellanno now joins a growing number of plaintiffs pursuing Exactech knee replacement lawsuits, alleging that their lives have been negatively effected when the implants failed prematurely, resulting in severe and permanent injuries.

According to the lawsuit, Dellanno underwent right total knee replacement surgery in November 2009, at which time he was implanted with an Optetrak Logic CC Tibial insert. That implant has now failed, and Dellanno is scheduled to undergo revision surgery in October 2022.

The lawsuit against Exactech alleges that the manufacturer knew long before announcing the recall that its implants had problems and repeated reports of failures, but the company failed to inform patients or the medical community.

“Defendants, however, ignored reports of early failures of their Optetrak Device and failed to promptly investigate the cause of such failures or issue any communications or warnings to orthopedic surgeons and other healthcare providers,” the lawsuit states. “Before the date of Plaintiff’s initial knee surgery, Defendants knew or should have known that the Optetrak Device was defective and unreasonably dangerous to patients, that the product had an unacceptable failure and complication rate, and that the product had a greater propensity to undergo substantial early polyethylene wear, component loosening and/or other failure causing serious complications including tissue damage, osteolysis, and other injuries as well as the need for revision surgery in patients.”

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.