Catalog Number UNK-ASR |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Swelling (2091); Synovitis (2094)
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Event Date 03/28/2016 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.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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Event Description
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Litigation documents received.Patient underwent a revision to address pain, synovitis, swelling, adverse local tissue reaction and elevated metal ions.
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Manufacturer Narrative
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Depuy considers the investigation closed.Should additional information be received the investigation will be reopened.
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Event Description
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Update 12/28/2016 ¿ medical records received.After review of the medical records for mdr reportability, it is noted that the initial implant surgery was an asr hip resurfacing, not an asr xl acetabular total hip as was originally submitted.Stem and sleeve products removed from complaint, mdr trees voided and medwatches updated accordingly.No prod/lot information available for remaining products.Revision operative note indicates findings of "hypertrophic fibrotic capsule and hypertrophic synovium, consistent with chronic adverse local tissue response and chronic effusion".No metal ion results available.
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Search Alerts/Recalls
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