Orthopedic devicemaker Exactech is facing hundreds of lawsuits filed on behalf of 1,100 patients who say they received faulty joint implants, KFF Health News reported Oct. 10.
Exactech began recalling artificial knee, hip and ankle implants in August 2021, the report said. In a letter shared with surgeons, the company said a packaging defect caused plastic in a knee component to wear out prematurely.
One patient, Ron Irby, had an artificial knee implanted in September 2018, and he expected the device to last at least 20 years, the report said. However, the device had to be replaced after three years. His lawsuit alleges that Exactech should have known the Optetrak "had an unacceptable failure and complication rate," the report said.
In its own filing, Exactech denied Mr. Irby's allegations, describing Optetrak as "safe and effective."
Orthopedic surgeons also said their patients' Optetrak devices were loosening within a few years of implantation. Wayne Moody, MD, said 25 of the 385 Optetrak operations he completed over four years had to be revised.
Several of the lawsuits also allege that Exactech did not warn patients and surgeons about knee implant loosening and instead replaced the finned tray component in a strategy called a "silent recall."
Attorneys for Exactech said the company may not be at fault for all implant failures. In a 2022 hearing, Exactech attorney Michael Kanute said implant wear is a "known risk no matter who makes them" and factors such as a patient's activity level could affect the device, the report said.