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New York Man Claims Exactech Knew About High Failure Rates but Failed to Warn Doctors

A New York man and his wife recently filed a new Exactech knee lawsuit in the U.S. District Court for the District of New York. The plaintiff claims that he sustained serious injuries from the Exactech Optetrak Comprehensive Total Knee System. He seeks both compensatory and punitive damages.

Patient Implanted with Exactech Knee Device

According to the complaint, the plaintiff went through total knee replacement surgery on his right knee on August 26, 2011. His surgeon implanted the Optetrak device, including an Optetrak PS Tibial Insert made of polyethylene.

Exactech later recalled this and thousands of other inserts because they were packaged in non-conforming vacuum bags. These bags lacked an additional oxygen barrier layer, which could increase the risk that the liner would be exposed to oxygen. Should that occur, the plastic may wear out earlier than expected, or become damaged after it’s implanted into the patient’s body.

The plaintiff knew none of this at the time of his operation because the company failed to warn patients or doctors of the issue. Even though liners manufactured since at least 2004 had been packaged in these non-conforming bags, Exactech did not implement the recall until February 2022.

Patient’s Exactech Knee Implant Fails, Requiring Revision Surgery

On March 5, 2019, the plaintiff was diagnosed with aseptic loosening and osteolysis (a condition in which bone is destroyed). He had to undergo risky revision surgery to repair his knee. During the surgery, his surgeon stated “the patient has very prominent osteolysis” and “the femoral component was noted to be loose.” (The femoral component is the one that attaches to the thigh bone.)

The plaintiff believes the loose components in the implant and the osteolysis developed because of premature wear of the now-recalled polyethylene tibial insert. Despite going through the revision surgery, he continues to suffer from pain that limits his ability to go about his daily activities.

Exactech Knew Its Devices Were Failing at Rates Higher Than Expected

Exactech has long touted its Opetrak devices as being safe and promoted them as having nearly three decades of clinical success.

Meanwhile, data showed that the devices were performing poorly when compared to other similar devices. During an examination of the Australian Registry, which contains information on joint implantations and revision surgeries, researchers found this to be the case. Out of 3,684 Optetrak TKRs, there were 374 revision procedures. This was a higher rate compared to other similar replacement systems.

Data from the United Kingdom Registry and the New Zealand Registry showed similar results, with Optetrak systems having a higher revision rate than other knee replacement systems.

As early as 2012, the manufacturer had clinical evidence that the devices were failing at a higher rate than promoted. Reports in the Manufacturer and User Facility Device Experience (MAUDE) indicated instances of revision due to “loose tibial component,” “aseptic loosening,” “polyethylene deformation,” and more.

The plaintiff notes that Exactech sales reps also observed “many instances of premature failures of the Opetrak Device with plain evidence upon revision of polyethylene debris that needed to get removed…”


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