Catalog Number 999804451 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); No Information (3190)
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Event Date 11/20/2008 |
Event Type
Injury
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Event Description
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Asr revision.Asr resurfacing - right.Reason(s) for revision: unknown.Bi-lateral patient - left hip is yet to be revised.
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Manufacturer Narrative
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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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Manufacturer Narrative
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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.1818910-2012-73024 is a duplicate report of 1818910-2014-35467.1818910-2012-73024 will be rejected.1818910-2014-35467 will be kept for investigation purposes.Depuy still considers this case closed to capa.
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Event Description
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New etq record created in order to update etq (legacy system) complaint number (b)(4).Reason for original complaint - asr revision, asr hip resurfacing system - right, reason(s) for revision: pain.Update - 19 dec 2014 from (b)(6) added kid number,surgeon name and hospital.*bi-lateral patient - left hip is yet to be revised.
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Search Alerts/Recalls
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