Catalog Number UNK-ASR |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Tissue Damage (2104); Injury (2348); Deformity/ Disfigurement (2360); No Code Available (3191)
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Event Date 05/02/2014 |
Event Type
Injury
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Event Description
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Patient contacted depuy as a result of the asr recall to initiate a claim.Medical records were obtained.Medical records indicate patient was revised due to pain.Upon revision, bursal tissue staining was noted and a bony defect was created when bone tissue remained on the acetabular cup while removing it.
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Manufacturer Narrative
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Additional narrative:
if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.(b)(4)
depuy still considers this investigation closed.
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Event Description
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Update rec'd 11/20/2014- litigation papers received.Litigation alleges pain, permanent physical injuries, disfigurement, and elevated metal ion levels.The doi was provided.The stem and sleeve are being added to the complaint.There is no new additional information that would affect the investigation.The complaint was updated on: 12/15/2014.
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Search Alerts/Recalls
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