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Catalog Number UNK-HIP |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problems
Pain (1994); Complaint, Ill-Defined (2331); Osteolysis (2377); Blood Loss (2597)
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Event Date 09/28/2015 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.
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Event Description
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Medical records received.Medical records reviewed for mdr reportability.Patient was revised for pain, osteolysis, and implant loosening.Revision surgical note reported a blood loss of 3000ml with no explanation, minimal metallosis, the femoral stem grossly loose, and a leg length discrepancy of 12mm.There were no component stickers so unknown depuy products will be reported until further information is received and the medwatch updated as appropriate.
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Manufacturer Narrative
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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.Wwcapa (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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Search Alerts/Recalls
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