Exactech, a medical device manufacturer that sells knee, hip and ankle implant devices has issued a series of recalls over the last year. Doctors and surgeons were notified of the problem with early failure of the implants in June 2021 but letters did not go out to patients until 2022. The letters urged patients who had received Exactech knee, hip, and ankle implants to schedule an appointment with their doctors for an evaluation to determine whether the polyethylene had deteriorated and whether surgery might be necessary to replace the implant.
The recall does not mean that all patients with the Exactech implants will need surgery to replace the recalled devices. It is not known yet how many of the implants have failed or will fail. It appears that the polyethylene which was used in the Connection GXL hip liner and in the Optetrak and Truliant knees and Vantage ankles is deteriorating and failing early.
Exactech has advised the surgeons that most of the knee and ankle inserts manufactured since 2004 were packaged in out of specification vacuum bags that are oxygen resistant but do not contain a secondary barrier layer containing ethylene vinyl alcohol that would further protect the device from exposure to oxygen. The exposure to oxygen in shipping and storage can severely degrade the polyethylene leading to accelerated wear debris production and bone loss in patients after implant. The wear debris from the deteriorating polyethylene causes bone loss in patients that frequently leads to failure of the device and the need for surgery to replace the device. A surgery to preplace the device is referred to as a revision surgery.
Several countries around the world keep registries of the failure rates of orthopedic implants according to the company that manufactured the device. These registries indicate that the Exactech implants have been failing at higher rates than the implants manufactured by other manufacturers. The Australian registry, in particular, show a high rate of failure of these devices.
The recall letters that have been received by patients in 2022 have been sent by their doctors but the letters were written by Exactech who recommended to doctors that they send the letters out on the medical practice letterhead.
There has been medical literature published that reviews the high failure rate of the Exactech GXL cross-linked polyethylene hip implants. An article in the Journal of Arthroplasty in May of 2020 discusses failures of the GXL hips between 2009 to 2019. The article concluded that the GXL liner failures it studied were not likely to be related to patient specific issues such as surgeon implant techniques or patient demographics such as weight or age.
Exactech Knee, hip, or ankle implant patients who have received one of these letters or who are having pain with their implant may be entitled to monetary compensation from the company and should seek legal counsel as soon as possible.
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