Catalog Number UNK HIP ACETABULAR LINER METAL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Pain (1994); Synovitis (2094); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/15/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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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Event Description
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Litigation complaint received ad 30 mar 2022.Unf and medical records received.After review of medical records patient was revised was due to failed total hip arthroplasty-trunnionosis, painful and elevated metal ion levels.Operatives notes indicated cobalt level was 7ppb.Chromium level was 4ppb.Diffuse metallosis with synovial staining, gross corrosion noted on the trunnion and within the internal bore of the femoral head.Acetabular component was well fixed but 2 screws were removed.Estimated blood loss is 1200ml.Doi: unknown, dor: (b)(6) 2020, left hip.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.E3 initial reporter occupation: lawyer.H6 clinical code: appropriate term / code not available (e2402) is used to capture blood heavy metal increased.
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Search Alerts/Recalls
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