Catalog Number 999804249 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); Osteolysis (2377)
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Event Date 07/15/2014 |
Event Type
Injury
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Event Description
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Asr revision due to take place (b)(6) 2014.Asr resurfacing system - left, reason(s) for revision: alval / soft tissue reaction and pain.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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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.(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 due to take place (b)(6) 2014, asr resurfacing system - left, reason(s) for revision: alval / soft tissue reaction and pain.Update - received confirmation that revision has taken place.Taken from (b)(6) spreadsheet dated 5th august 2014.Update received 11th september 2014.(b)(4) is a duplicate of this com and has been sent to void.Attachment transferred.Amended status to "clinical trail", reference number added.Patient details added.Taper sleeve added.Additional reasons for revision added.Expiry dates added.Reason(s) for revision: alval / soft tissue reaction and pain.Mechanical loosening of internal prosthetic joint (cup).Bony tissue necrosis, osteolysis.
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Search Alerts/Recalls
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