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.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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Depuy considers the investigation closed at this time.Should the 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 will be filed as appropriate.
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New legal claim received from (b)(6), xl system, right hip, revision has not taken place yet.(b)(4) update alert date 4th oct 2016.Attached scf, added revision date, added reasons for revision x 3 , added surgeons x 2 , added additional hospital, added full sleeve details and product code for stem, added manufacturing date for sleeve.Taken from scf dated (b)(6) 2016 and claimsuite dated (b)(6) 2016.Reason(s) for revision: component loosening : cup, osteolysis and metallosis update june 30, 2017 additional information received from kennedy, date of revision: (b)(6) 2016.The reported event has been evaluated and will be monitored.Depuy considers the investigation closed at this time.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 will be filed as appropriate.
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