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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
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.
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 ]
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]
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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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