Catalog Number UNK HIP FEMORAL HEAD METAL ASR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 04/13/2021 |
Event Type
Injury
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Manufacturer Narrative
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(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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It was reported that the original surgery date unknown.Suspected metalosis.Doi: unknown, dor: (b)(6) 2021 right 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.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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 manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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Search Alerts/Recalls
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