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2010 DePuy Hip Recall
The 2010 DePuy Hip Replacement Recall was instituted when DePuy Orthopaedics, Inc., a division of Johnson and Johnson, recalled its ASR XL Acetabular metal-on-metal hip replacement system on August 24, 2010.
==Background==
The DePuy ASR XL Acetabular System first became available in 2005 in the United States. Johnson & Johnson was given special clearance from the FDA in 2005 to market the ASR devices without first performing clinical trials—tests to determine the safety of the products. Since 2008, the FDA has received approximately 400 complaints from patients who received ASR hip replacements. In March 2010, J&J acknowledged that ASR products had a higher-than-normal failure rate after data revealed that approximately 12% of patients who received an ASR device needed “revision surgery.” In August 2010, DePuy issued a voluntary recall of both ASR devices, more than a year and a half after the first lawsuit was filed. Many experts agree that a recall should have been issued sooner, due to the high volume of complaints about the devices.
The recall came after data from a study indicated that the five year failure rate of this product is approximately 13%, or 1 in 8 patients. Even if the defective device is replaced, it can leave behind dangerous, possibly deadly fragments that may not be discovered for years. DePuy identified reasons for the failure of the hip replacement system as component loosening, component malalignment, infection, fracture of the bone, dislocation, metal sensitivity and pain. Additional complications from the hip replacement system may include increased metal ion levels in the blood, bone staining, necrosis, swelling, nerve damage, tissue damage and/or muscle damage.
At the beginning of 2010, DePuy Orthopaedics said they were phasing out the ASR Hip Implant because of declining sales, but never mentioned the high failure rate data from an Australian implant registry. In March 2010, the New York Times reported that DePuy issued its first warning to doctors and patients about the high early failure rate.〔 However, at this point, they still had not issued a recall of the product. In fact, they claimed any statements referencing a recall were false.
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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