Biomet Hip Replacement Implant Recall
Biomet Hip Replacement Implant Recall System
In February 2001, the FDA announced that Biomet, US manufacturer of artificial hips, had made a voluntary recall of its hip replacement system following discovery of defects in the zirconia ceramic femoral heads. The ceramic femoral head components had been produced by the French manufacturer Saint Gobain Desmarquest, which distributes zirconia ceramic femoral heads to the orthopedic industry throughout the world.
Biomet recalled the defective product from the market after it found that the device was vulnerable to fracture at a higher than expected rate, causing failure of the hip implant system within 13 28 months. The recall applies to nine lots of the non implanted ceramic femoral head components, also known as Prozyr® Zirconia Heads, produced from January 1998 to September 1999, when Saint Gobain Desmarquest changed its manufacturing process, especially the heating procedure of the ceramic heads. However, the change is believed to have caused a negative impact on the ceramic femoral head components, which were found to become unstable soon after implantation.
Several other manufacturers of hip implants used this defective component in their hip replacement systems, including DePuy Orthopedics, Stryker Howmedica Osteonics, Encore Orthopedics, Smith & Nephew Inc., Osteoimplant Technology, Apex Surgical, and Zimmer Inc. The batch number of the recalled ceramic femoral head batches has the prefix "TH." The recall only applies to ceramic femoral heads produced since the early 1998. It does not affect any femoral heads made of alumina ceramic.
Following the Biomet recall, all these companies followed suit and withdrewtheir artificial hip replacement systems from the market, saying that the product could fail and fracture, following which the patient would need to undergo a replacement and revision surgery. Even surgeons complain that they find it hard to remove and replace the defective components.
The FDA stated that there were problems with the ball portion of the artificial hip joint, which connects the pelvis and the femoral stem. Reports claim that the ball portion of the artificial hip joint is faulty, which has a propensity to become unstable and thus cause fracture. There are many cases where patients have reported to have heard a popping sound from their hip just before the device fractured, following which they started experiencing excruciating hip and groin pain.
The FDA received a number of reports that the components