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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Asr revision asr resurfacing right reason(s) for revision: collum fracture update rec'd (b)(4) 2017 - additional information was received.The patient experienced a collum fracture along with pain on (b)(4) 2008 with no history of trauma.At this time there is no new information that would change the existing mdr decision.The complaint was updated on: (b)(4) 2017.Update (b)(4) 2017: email notification received.Corrected the dor and updated the complainant address.This complaint was updated on (b)(4) 2017.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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