Polyethylene Insert in Recalled Exactech Knee Implant Failed, Leading to Revision Surgery, Lawsuit Claims

Plaintiff’s failed polyethylene insert was replaced with another Exactech implant, which doctors now say he should also get removed.

A New York man indicates in a recently filed lawsuit that the polyethylene insert in his recalled Exactech knee implant failed, resulting in the need for additional surgery to have the implant removed, and leaving him with permanent injuries.

The complaint (PDF) was filed last week by John Ametrano and his wife, Angela, in the U.S. District Court from the Southern District of New York, indicating that an Exactech Optetrak Comprehensive Total Knee System used during his original surgery was shipped with a defectively packaged polyethylene inserts, which caused caused the knee implant to fail.

An Exactech knee recall was issued in February 2022, impacting more than 140,000 components implanted since 2004, which were distributed in “out-of-specification” vacuum bags, which failed to prevent oxygen from reaching a plastic insert before it was placed in the body. This resulted in oxidation of the components, leading to an alarmingly high failure rate within a few years after knee replacement surgery.

The case joins a growing number of Exactech knee lawsuit filed since the recall, each of which describes similar problems where an Exactech knee failed and resulted in the need for revision surgery.

Ametrano indicates he underwent left total knee replacement in March 2012, during which he was implanted with an Optetrak Total Knee system that included an Optetrak Logic Polyethylene Tibial Insert.

Although knee replacements are typically expected to last about two decades, Ametrano required a left knee revision surgery only six years later, due to the failure of the polyethylene tibial insert. However, during the revision surgery, he was implanted with a second polyethylene tibial insert, which was later recalled and now Ametrano’s doctors recommend he undergo a second revision surgery to remove that insert as well.

The lawsuit claims Ametrano has suffered permanent injuries and will have to undergo more surgical procedures due to the device’s defective design.

“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,” the lawsuit states. “Recipients of the Device, like the Plaintiff, have been required to undergo revision surgeries well before the estimated life expectancy of a knee implant and at a much higher rate than should reasonably be expected for devices of this kind and have suffered pain and disability leading up to and after the revision surgery.”

March 2023 Recalled Exactech Knee Implant Lawsuit Update

There are currently more than 132 Exactech knee replacement lawsuits and Exactech hip replacement lawsuits centralized before U.S. District Judge Nicholas G. Garaufis in the Eastern District of New York, since they each involve similar questions of fact and law about whether “out-of-specification” vacuum sealed bags caused a plastic tibial insert component to fail, leading to risky revision surgery.

As part of the management of the litigation, it is expected that Judge Garaufis will establish a “bellwether” process, where a small group of representative claims will go through a case-specific discovery process and be prepared for early test trials.

On February 8, Judge Garaufis issued a docket order scheduling the Science Day for the morning of May 10, 2023, at the Alachua County Family and Civil Justice Center in Gainesville, Florida, before both himself and two state court judges presiding over similar cases. The parties were asked to submit a joint report by March 13, 2023, confirming their availability and proposing an agenda, and did indicate that alternate dates in May or June 2023 could be proposed if the selected date does not work for the parties.