Catalog Number 999890151 |
Device Problems
Naturally Worn (2988); Insufficient Information (3190)
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Patient Problems
Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); Tissue Damage (2104); Osteolysis (2377)
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Event Date 03/14/2014 |
Event Type
Injury
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Event Description
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Asr revision; right; asr xl; reason(s) for revision: alval / soft tissue reaction.Update received: (b)(4) 2014 - added manufacturing dates, added taper sleeve common name and corrected construct type and amended revision date: (b)(6) 2014.Update - received confirmation that revision has taken place.Taken from (b)(6) spreadsheet dated (b)(6) 2014.
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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.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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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.Right.Asr xl.Reason(s) for revision: alval / soft tissue reaction.Update received: 31st march 2014 - added manufacturing dates, added taper sleeve common name and corrected construct type and amended revision date: (b)(6) 2014.Update - received confirmation that revision has taken place.Taken from (b)(6) spreadsheet dated 15th april 2014.Update - added a hospital.Taken from claimsuite dated 7th july 2014.
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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.Right.Asr xl.Reason(s) for revision: alval / soft tissue reaction.Update received: 31st march 2014 - added manufacturing dates, added taper sleeve common name and corrected construct type and amended revision date: (b)(6) 2014.Update - received confirmation that revision has taken place.(b)(4).Update - added a hospital.Taken from claimsuite dated 7th july 2014 (b)(4).Reason(s) for revision: alval / soft tissue reaction, wear of articular bearing surface of internal prosthetic joint, bony tissue necrosis, patient demand, osteolysis, physician recommendation, pain.
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Search Alerts/Recalls
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