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A New York woman recently filed a new Exactech lawsuit in the Southern District of New York. She claims that after she was implanted with the Exactech Optetrak Comprehensive Total Knee System, she suffered from serious injuries.

Plaintiff’s Exactech Knee Implant Fails Prematurely

According to her complaint, the plaintiff underwent left knee replacement surgery on February 18, 2014. Her surgeon implanted the Optetrack device at the Hospital for Special Surgery (HSS) in New York, New York.

On May 11, 2022, an MRI scan of the plaintiff’s right knee showed synovial expansion, which means that the connective tissue inside the joint was inflamed and swollen. There was evidence of debris, consistent with premature wear of the plastic lining in the knee replacement device. This sits between the two metal components attached to the thigh bone and the shin bone. It serves as a shock absorber for the knee joint.

On May 17, 2022, a CT scan of the knee showed osteolysis—the destruction of the bony tissue—around the right knee implant. Meanwhile, the plaintiff was suffering from worsening pain and instability in that joint.

Because of these issues, she underwent revision surgery on the right knee on June 7, 2022. During that surgery, her orthopedic surgeon stated that the femoral (thigh) component of the device was loose. He identified osteolysis in many areas of the knee joint, which were due to premature polyethylene wear of the tibial insert.

Defendants Were Aware of Issues Long Before the Recall

Exactech issued a recall of all its polyethylene inserts in February 2022, revealing at that time that since 2004, they were all been packaged in non-conforming vacuum bags. These bags could expose the inserts to oxygen in the air, potentially causing degradation and leading to premature wear and tear once the device was implanted.

The plaintiff notes, however, that as early as 2007, the manufacturers were aware that their devices were not performing as expected.  That year, the Australian Joint Registry found that the Optetrak-PS femoral component—when used with an Optetrak tibial component—resulted in a 6.23 percent revision rate at three years and a 6.64 percent revision rate at four years. These were higher than anticipated.

This was only the beginning. Problems continued, with the registry regularly showing that the Optetrak device was having higher than normal revision rates compared to other knee joint implants. Failure rates for the Optetrak device in the United Kingdom registry were similarly high, yet Exactech continued to market and sell the devices for years.

Exactech acknowledged these issues but not until it recalled the inserts. At that point, the company cited 2021 Australian Registry data.

Exactech Lawsuits Proceeding in New York

The U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federally filed Exactech lawsuits into the Eastern District of New York on October 7, 2022. The parties are now working together under the direction of District Judge Nicholas G. Garaufis to prepare a small number of cases for early trial.

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