In August of 2010, Johnson & Johnson subsidiary DePuy recalled both its ASR and ASR XL hip replacements systems after growing pressure from the FDA over the devices' unusually high failure rate. And doctors in the United Kingdom have reported that DuPuy products have a failure rate as high as 49% after only six years. The reports of problems with various metal-on-metal designs has become so troubling that on May 6, 2011, the Food and Drug Administration ordered a study of 145 different metal-on-metal hip replacements designs made by 21 different manufacturers. As the metal ball-and-joint scrape against each other, tiny particles of metal debris wear off within the patient. The particles can float freely within the joint, embed into nearby tissue or even enter the bloodstream, causing havoc on the patient's body.
The Durom Cup was first sold in the U.S. by Zimmer, in 2006, and it was implanted in more than 12,000 Zimmer hip replacement patients over the two-year period from the Summer of 2006 to the suspension of sales in July 2008. Based on information received from discussions with hip surgeons throughout the country, estimates on the failure rate of the Zimmer Durom Cup hip replacement range between 20% and 30%. The true failure rate of the Zimmer Durom Cup may climb much higher in the coming years as doctors and their patients come to realize that their implants are gradually failing.
In February 2011, The FDA launched a new website, which was designed to provide information about the risks associated with metal-on-metal hip replacements. The FDA has now asked device manufacturers to obtain more information about the level at which the metal particles shed by hip replacements becomes dangerous, how much metal they actually shed and what the potential side effects of metallosis are. Zimmer’s own estimates in 2008 suggested that some doctors in the United States experienced failure rates as high as 5.7%, while more recent claims made in Zimmer Hiplawsuits suggest that the artificial hip failure rate is between 20% and 30%. Certain Zimmer hip components were recalled due to inconsistent geometry and non-conforming designs.