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The defective polyethylene insert failed due to defective packaging, leading to the plaintiff requiring revision surgery some time in the future.

Defective packaging of a polyethylene insert caused the failure of an Exactech Trulient knee replacement, according to allegations raised in a lawsuit brought by a Louisiana man who says he now requires additional surgery to have the implant removed and replaced.

The complaint (PDF) was filed this week by Gary Cheramie in the U.S. District Court for the Eastern District of Louisiana, indicating that his Exactech Trulient knee was one of more than 140,000 implants recalled earlier this year.

An Exactech recall was issued in February 2022, after the manufacturer acknowledged that defective vacuum bags were used to package polyethylene inserts included with Optetrak, Optetrak Logic and Truliant total knee replacement systems sold since 2004, which exposed the plastic tibial inserts to oxygen before they were implanted. Several hip and ankle implants were also recalled.

As a result of the packaging, oxidation may cause the knee replacements to fail prematurely, usually resulting in the need for early revision surgery, and hundreds of individuals nationwide are already pursuing Exactech knee lawsuit, alleging that they have been left with severe and permanent injuries.

Design problems with several types of knee implants have resulted in lawsuits for individuals who experienced painful complications.

Cheramie’s complaint indicates he underwent knee replacement surgery in June 2021, at which time he received a Truliant Total Knee System. However, only a few weeks after surgery, Cheramie began to complain of significant pain in the knee and there was apparent loosening of the device.

“Over a year after his surgery, Plaintiff continues to have significant pain and instability in his left knee due to the Truliant Device and has had worsening pain, instability and swelling, is unable to bear weight on his knee, and cannot walk or exercise without pain and assistance,” the lawsuit states. “Recently, Plaintiff was informed by his physician that the only way to correct the problem and potentially alleviate the pain in his left knee is to have revision surgery, which Plaintiff intends to have done.”

Cheramie’s lawsuit blames the problems on the Truliant polyethylene insert, which was subjected to the packaging recall.

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 contact knee replacement lawyers in the coming weeks and months, it is widely expected that thousands of similar lawsuits will be filed throughout the U.S. Court system.

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