Lawsuit Alleges Exactech Knee Complications Resulted From Defectively Packaged Tibial Component

A defectively packaged tibial insert caused a Delaware man to experience painful complications with his Exactech knee replacement, which failed prematurely after the component was exposed to oxygen before surgery, resulting in the need for revision surgery to replace the implant.

The complaint (PDF) was filed by Joseph Sexton in the U.S. District Court for the District of Maryland on November 11, indicating he was one of thousands of individuals who received Exactech components that were packaged in “out-of-specification” vacuum sealed bags, which caused the plastic tibial insert to oxidize and deteriorate.

The manufacturing problems resulted in a massive Exactech recall in February 2022, impacting more than than 140,000 Optetrak, Optetrak Logic and Truliant knee replacement systems implanted in patients since 2004, as well as 1,500 similar components used in Exactech Vantage ankle replacements, which were each sold with defectively packaged tibial inserts that were exposed to oxygen before they were used, causing the plastic component to oxidize and deteriorate.

Similar hip replacement recalls have been also issued for more than 130,000 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.

According to the complaint, Sexton received an Optetrak Total Knee replacement system in his right knee in November 2006. While there were no issues during or immediately after the surgery, and the knee replacement performed as expected for several years, over time he began experiencing “popping”, “locking up”, pain, swelling, instability and eventually an inability to bear any weight on his right knee, resulting in the need for a cane and knee brace.

“In the years following the surgeries, Plaintiff Joseph D. Sexton experienced pain, swelling, instability, and bone loss in his right knee caused by early and accelerated polyethylene wear and/or component loosening,” the lawsuit states. “Ultimately, on October 9, 2018, Plaintiff underwent an extensive revision surgery on his right knee.”

The lawsuit indicates Sexton is one of many Optetrak knee implant recipients who have had to undergo painful revision surgeries long before the devices were expected to fail, due to defectively packaged tibial components that are now known to fail at much higher rates than should be anticipated.

Sexton’s claims Exactech knew its Optetrak implants were defective for years due to the product packaging error, but failed to warn consumers or the medical community, but waited to recall the devices for as long as possible to increase profits at the expense of patient safety.

Sexton’s lawsuit presents claims of strict product liability, failure to warn, breach of warranty, fraud and negligence.

Exactech Knee Implant Failure Lawsuits

Sexton’s caase joins a 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.