Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.Initial reporter occupation: lawyer.(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 revision, asr xl , left hip, reason(s) for revision: pain, difficulty walking, swelling, rom restricted, blood cobalt chromium raised, osteolysis, metallosis and "collution" present.Doi: (b)(6) 2009 - dor: (b)(6) 2020 (left hip).
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