Patient contacted depuy as a result of the asr recall to initiate a claim.Medical records were obtained.Medical records indicate patient was revised due to discomfort, joint effusion and elevated metal ion levels (co 370, cr 1100).Upon revision, brownish fluid, ruptured sutures posteriorly, partially intact external rotators, extensive scar tissue, and corrosion on the femoral neck from the femoral head were noted.
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The asr platform was voluntarily recalled from the market in august 2010, and the asr product codes are now considered inactive.Further investigation of this individual incident will not be undertaken, as there is an ongoing investigation regarding the root cause(s) and/or corrective actions.Ref.Wwcapa (b)(4).Depuy considers the investigation closed at this time.Should the product and/or additional information be received, the investigation will be re-opened.
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