Catalog Number 999890151 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
No Information (3190)
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Event Date 05/10/2006 |
Event Type
Injury
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Event Description
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Asr revision; left; xl; reason for revision : component loosening - head.All xl products revised on (b)(6) 2006.Head was replaced and sleeve implanted on the same date and cup was left in situ.For this information (the second revision) see (b)(4).Bi-lateral patient.For right side see (b)(4).
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Manufacturer Narrative
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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.(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.Depuy still considers this case closed to capa.
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Event Description
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Asr revision, left, xl, reason for revision : component loosening - head.All xl products revised on (b)(6) 2006.Head was replaced and sleeve implanted on the same date and cup was left in situ.For this information (the second revision) (b)(4) bi-lateral patient.For right side (b)(4).Update - the stem component became loose not the head as previously stated.A unknown stem hip implant has now been added to this complaint.Response to patient demographics request.See email dated 2nd october 2014.Patient sex and date of birth given but this is all the info provided at this time.
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Search Alerts/Recalls
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