The U.S. Food and Drug Administration (FDA) has proposed new regulatory rules that, if passed, will require orthopedic device manufacturers to test their all-metal hip replacement and resurfacing systems for safety and efficacy before approval. The proposed measures come in response to alarmingly high rates of failure and injury associated with metal-on-metal hip devices, such as the ASR XL Acetabular and Hip Resurfacing Systems made by DePuy Orthopedics, which were recalled for safety concerns in August 2010 after being implanted in about 93,000 patients worldwide, including approximately 40,000 Americans. The FDA’s proposed order would require manufacturers to file a premarket ... Read More
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