Exactech Logic Knee Lawsuit Filed Over Premature Liner Failure, Which Resulted in Revision Surgery

The premature failure of the polyethylene liner on an Exactech Logic knee implant caused an Indiana woman to require revision surgery only six years after her knee was replaced, according to allegations raised in a product liability lawsuit filed last week, which indicates that thousands of similar Exactech knee replacements may be prone to fail due to a widespread manufacturing defect.

The complaint (PDF) was filed by Mary Cirrito and her husband, Michael, in the U.S. District Court for the Eastern District of New York on November 25, indicating that she received a defective Exactech Logic knee implant, which was later recalled due to a risk of premature liner failure.

Manufacturing problems resulted in polyethylene liners used with more than 140,000 Optetrak, Optetrak Logic and Truliant knee replacement systems being distributed since 2004, with “out of specification” vacuum sealed bags that exposed the plastic tibial insert oxygen before it was implanted, leading oxidization and deterioration of the component.

The massive Exactech recall was issued in February 2022, also impacting more than than 1,500 similar components used in 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.

The lawsuit indicates Cirrito’s surgeons used an Exactech Optetrak Logic Total Knee system in her right knee in July 2012. The Exactech Logic knee implant was supposed to last for a significant number of years before needing replacement or experiencing the risk of failure. However, within about five years, Cirrito began experiencing swelling and pain in her right knee. An MRI of the knee detected the presence of synovial debris, which is consistent with polymeric wear.

She underwent revision surgery in January 2018, to have the tibial insert replaced. However, she later learned that the insert used during her surgery was also impacted by the Exactech recall, and that the manufacturer knew it was susceptible to the same early wear as the previous insert that failed.

“As a result of Defendants’ failure to properly package the Optetrak Device prior to distribution, the polyethylene liner prematurely degraded and Plaintiff required revision surgery due to severe pain, swelling, and instability in the knee and leg,” Cirrito’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.”

Exactech Knee Implant Failure Lawsuits

Cirrito’s case 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.

Last month, 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.