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.
We just hope that after all these mess from zimmer hip recall , all would be well.
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