Side Effects & Recall Lawsuit
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 componentsfractured easily and thus needed to be removed and replaced. This caused patients immense pain. The patients further complained of grinding sensations, reduced range of motion following their hip replacement surgery using components of zirconia ceramic femoral heads.
Biomet hip replacement failure symptoms include groin pain, grinding sensation in the hip region, audible popping sound just before hip replacement failure, which necessitates revision surgery.
Hip Replacement And Other Biomet Recalls
Biomet recalled its Tibial Bearing ARCOM UHMWP in 2007 due to improper laser etching for size. Again in 2008, Biomet recalled its Modular Microplasty Cup Inserter used for hip prosthesis over reports of breakage of the weld at the lock location during impaction, especially when it was pressed and firmly fixed.
In August 2001, Biomet recalled its hip replacement system that used ceramic femoral head components. Since February 4, 2002, the French manufacturer admitted that it had reported 162 breakages of the ceramic femoral heads, which required extensive revision surgery. The documents produced by St. Gobain clearly point toward the number of affected lots of femoral heads; however, it is still unknown as to how many of the 9,051 femoral heads failed, which had been implanted into patients before the recall.
Before the recall, the ceramic heads had been recommended as an effective product for the treatment of complications arising from rheumatoid arthritis, osteoarthritis of the hip, avascular necrosis, traumatic injury to the hip, and developmental abnormality or infection of the hip.
Biomet Hip Replacement Implant Surgery in the US
Reports state that more than 150,000 200,000 patients undergo hip replacement surgeries every year in the United States, of which six percent receive a defective synthetic hip, which causes them pain and suffering. Further, such patients require a revision surgery to replace the defective hip replacement system.
If you or any of your loved one has undergone implantation with Biomet hips, you must approach your physician for regular monitoring because no test can determine whether a hip replacement manufactured by Biomet will fail. However, the FDA does not recommend replacement and revision surgery for all ceramic femoral heads, as not all patients experience such a problem and, therefore, all such devices are not expected to fail and fracture. Therefore, it is of utmost importance for those patients who have undergone hip replacement surgery using Biomet femoral heads to visit their physician if they experience pain or any other complication.
Biomet Hip Replacement Recall Lawsuit
Biomet is already facing thousands of lawsuits for marketing defective products, which have caused immense physical and mental pain, severe discomfort, to the plaintiffs. The plaintiffs claim that Biomet failed to inform them of the possible adverse effects related with its zirconia ceramic femoral heads. The patients also complain that the audible popping sound had caused them public humiliation, and they felt disgraced. Blaming the manufacturer for their suffering, many patients claim that the Biomet hip replacement system, which was meant to improve their mobility, exposed them to greater risk and caused them to suffer life threatening adverse effects.