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The 2010 DePuy Hip Replacement Recall was instituted when DePuy Orthopaedics, Inc., a division of Johnson & Johnson, recalled its ASR XL Acetabular metal-on-metal hip replacement system on August 24, 2010. [1] [2]
On August 24, 2010, DePuy recalled [4] all ASR hip implant systems sold since 2003. The 2010 DePuy Hip Recall was issued after research released by the National Joint Registry (NJR) found high rates of hip replacement failure for the ASR XL Acetabular and ASR Hip Resurfacing systems.
The analysis of 402,051 hip replacements showed that 6.2% of metal-on-metal hip implants had failed within five years, compared to 1.7% of metal-on-plastic and 2.3% of ceramic-on-ceramic hip implants. Each 1 mm (0.039 in) increase in head size of metal-on-metal hip implants was associated with a 2% increase in failure rate. [63]
Between its massive over-the-counter children's medicines recall back in 2010 to its recent headache-inducing hip implant recalls, J&J
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Johnson & Johnson and its DePuy Orthopaedics unit have agreed to pay $120 million to resolve deceptive marketing claims by several U.S. states.
Hip resurfacing has been developed as a surgical alternative to total hip replacement (THR). The procedure consists of placing a cap (usually made of cobalt-chrome metal), which is hollow and shaped like a mushroom, over the head of the femur while a matching metal cup (similar to what is used with a THR) is placed in the acetabulum (pelvis socket), replacing the articulating surfaces of the ...
Medical device cleanliness has come under greater scrutiny since 2000, when Sulzer Orthopedics recalled several thousand metal hip implants that contained a manufacturing residue. [56] Based on this event, ASTM established a new task group (F04.15.17) for established test methods, guidance documents, and other standards to address cleanliness ...