Product complaint # (b)(4).Investigation summary.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.The investigation regarding the root cause(s) and/or corrective actions was conducted under mdd capa (b)(4).Ongoing post market surveillance is conducted per our procedures for this product.No 510(k) number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.The correction/removal reporting number listed applies to the corresponding product code sold domestically.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Asr claim letter (english) record received.Claim letter alleges elevated metal ions resulting to myocardial infarction, neo-formations, fibroid tumor, walking difficulty, anxiety and distress.Doi: (b)(6) 2008; dor: not revise; left hip.This complaint is link to (b)(4) (1st revision left hip).
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