Catalog Number UNK HIP ACETABULAR CUP ASR |
Device Problem
Noise, Audible (3273)
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Patient Problems
Fatigue (1849); Pain (1994); Ambulation Difficulties (2544); Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.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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Asr revision.Medical records received.After review of medical record patient was revised to addressed pain and elevated metal ions levels.Patient experiencing limping, popping, weakness and left is shorter than his right hip.There was some mascroscopic deposition at the base of the trunnion however there was no mascroscopic damage in the trunnion.Doi: (b)(6) 2009; dor: (b)(6) 2020; left hip.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.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 previous investigations that have included device history reviews since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing, or inspection.Therefore, no device history record (dhr) review for this individual asr component will be carried out at this point in time.
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Search Alerts/Recalls
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