The literature article entitled, "failure modes of 433 metal-on-metal hip implants: how, why, and wear" written by edward ebramzadeh, phd, patricia a.Campbell, phd, karren m.Takamura, ba, zhen lu, phd, sophia n.Sangiorgio, phd, jeremy j.Kalma, ba, koen a.De smet, md, and harlan c.Amstutz, md published by orthopedic clinics 2011 was reviewed.The article's purpose: "the aim of this study was to investigate the modes of failure in a larger collection of metal-on metal thrs and hip resurfacings and to examine the correlations between the reasons for revision and a range of patient and implant variables related to wear." data was compiled from 433 metal-on-metal retrieved between 1991 and 2010 (9 were postmortem).Depuy products: asr resurfacing implants.Adverse events: acetabular loosening, femoral neck fractures, malposition cups, metal allergy, pseudotumors, pain, alval, bearing wear.The article does not provide adequate information to determine accurate quantities.
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Product complaint # (b)(4).Investigation summary = > this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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