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Medical Device Alert: DePuy ASR TM acetabular cups used in hip resurfacing arthroplasty and total hip replacement, Medicines and Healthcare products Regulatory Agency, MDA/2010/044, 25 May 2010; Medical Device Alert: All metal-on-metal (MoM) hip replacements, Medicines and Healthcare products Regulatory Agency, MDA/2012/008, 28 February 2012
Though rare, metallosis has been observed at an estimated incidence of 5% of metal joint implant patients over the last 40 years. Women may be at slightly higher risk than men. If metallosis occurs, it may involve the hip and knee joints , the shoulder , [ 2 ] wrist , [ 3 ] elbow joints , [ 4 ] or spine . [ 5 ]
On February 10, 2011, the U.S. FDA issued a patient advisory on metal-metal hip implants, stating it was continuing to gather and review all available information about metal-on-metal hip systems. [4] On June 27–28, 2012, an advisory panel met to decide whether to impose new standards.
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]
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.
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Some countries exclude hemiarthroplasties done for traumatic hip fractures. Initially designed only to record surgeon and implant performance, the main outcome collected was implant failure , however recently patient-reported outcome measures are being added.
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