In June 2021, Exactech issued an urgent letter to orthopedic surgeons concerning the high failure rate of its GXL hip implant liners. There have been several articles in the medical literature questioning the early failures of the GXL hip implant liners. Exactech has also sent recall letters to some patients.
In 2019, Exactech removed the GXL liners from the US market in favor of a new product called the XLE liner. The medical literature and reports had shown hip implant patients with the GXL liner that had premature wear of the polyethylene and failure of the liners requiring revision surgery. Exactech sold almost 90,000 of these liners which were implanted in patients before it was removed from the market in 2019.
The GXL liners that have been failing were designed for use with the Exactech Novation, Accumatch and MCS hip implant systems.
Industry standards in the hip implant manufacturing community require that implants have a failure rate of less than one percent per year. That means that after 10 years 90% of implants should still be functional and after 20 years 80% of hip implants should remain functional. The Exactech implant failures with a GXL reported to the company are occurring between three and six years from the initial implant surgery.
In the Exactech June 2021 letter to surgeons it advises them to ask patients who are less than six years from the implant surgery and who have not been seen in over 12 months to return to the doctor’s office. Their doctor can then perform a routine set exam and x-rays to evaluate the wear on the GXL liner and consider revising the liner to the new XLE. The new Exactech product is the HXLPE vitamin E liner.
Not all hip implant patients with an Exactech GXL liner will require a revision surgery to replace the implant or replace the liner but those patients who are showing excessive wear and the liner will require another surgery for replacement.
A recent lawsuit filed by our law firm in Gainesville, Florida which is the headquarters of Exactech will require the company to produce internal documents so that it can be determined how long the Company has known about this problem and why these defective implants where implanted in almost 90,000 patients.
It is not clear how many GXL hip implant patients will require revision surgery or who are aware that their implant may fail. We expect to file several more lawsuits in the next few months for individuals who have come to us who have suffered an additional surgery because of the failure of their Exactech implants. The United States Food and Drug Administration, the FDA, requires reporting of hip implant failures but many failures are not reported. Therefore, we do not know how pervasive this problem has been.
If you have had a failure of an Exactech hip implant please contact us so we can review your case and be sure the failure is reported to the FDA.
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