Exactech Total Knee Failure Resulted in Revision Surgery, Lawsuit Alleges

Plaintiff says the manufactures knew about Exactech Total Knee failure risks before she got the device implanted, but failed to warn the medical community.

A New York woman indicates she had to undergo revision surgery after experiencing an Exactech Total Knee failure, alleging in a recently filed lawsuit that the problems were the result of a packaging defect which allowed oxygen to reach a plastic component before it was implanted, leading to premature degradation.

The complaint (PDF) was filed by Linda Safran in the U.S. District Court for the Southern District of New York on December 22, naming Exactech, Inc. as the defendant.

The manufacturer issued an Exactech recall in February 2022, after disclosing problems with the packaging of polyethylene liners used with more than 140,000 Optetrak, Optetrak Logic and Truliant knee replacement systems implanted since 2004.

“Out of specification” vacuum sealed bags caused the oxidation of plastic tibial inserts, leading to alarmingly high failure rate with Exactech total knee replacements involving the recalled component.

Similar packaging defects also resulted in the call of 1,500 Exactech Vantage ankle replacements, as well as more than 130,000 hip replacement systems that included a Connexion GXL liner, which have also been found to wear out prematurely and fail, often resulting in the need for revision surgery only a few years later.

Safran indicates she underwent left knee replacement surgery in 2014, at which time she was implanted with an Exactech Optetrak Comprehensive Total Knee System. However, in May 2022, an MRI detected signs of debris in her right knee, and a CT scan found osteolysis occurring around the Exactech total knee implant.

After experiencing worsening pain and instability, Safran underwent right knee replacement revision surgery to remove the failed Exactech Total Knee implant. The lawsuit claims Exactech knew there were problems with the implants for years, but failed to warn 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,” Safran’s lawsuit states. “Before the date of Plaintiff’s initial knee replacement 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.”

Exactech Knee Implant Failure Lawsuits

Safran’s claim joins dozens of Exactech knee lawsuits now being pursued in the federal court system, each involving similar allegations that the manufacturer knew or should have known about high failure rates associated with its implants long before doctors and patients were warned about the 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 November, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all Exactech lawsuits in an MDL, or multidistrict litigation, and transferred the claims to U.S. District Judge Nicholas G. Garaufis in the Eastern District of New York, to coordinated discovery into common issues in the claims, avoid conflicting pretrial schedules and to serve the convenience of common witnesses and parties involved lawsuits that were spread out throughout the federal court system.