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.(b)(4).
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Asr revision to take place on (b)(6) 2015.Asrxl - right hip.Reasons for revision: pain, noise, bone damage around the acetabular component.Update: 9 july 2015.The reply to query about what bone damage occurred states ".It is noted on the radiology report that there is a focal bony resorption above the right acetabular cup".Reply attached to 1st query as well as the medical report.((b)(4)) update 10 august: revision confirmed by crawfords.See spreadsheet.(b)(4).
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