Asr revision to take place on (b)(6) 2014.Asr xl.Right.Reason(s) for revision: alval / soft tissue reaction, pain, increased metal ions.Correction added (b)(6) 2014 - complaint categories amended.Dummy products for stem and taper sleeve added in order to report metal ions.Update - received confirmation that revision has taken place.Taken from (b)(4) spreadsheet dated (b)(6) 2014.
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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.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.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.(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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