Model Number 1218-87-352 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/07/2021 |
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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It was reported that the original implant date was unknown.Pt had elevated cobalt 7.9 chromium 2.3 levels.She was revised for those elastase metal ion levels.Corrosion was seen at the head and neck junction.The metal liner was removed, the metal head was removed and both were replaced with a poly liner and ts ceramic head.The summit stem was well fixed and the cup was well fixed.Doi: unknown.Dor: (b)(6) 2021, affected side: 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 device manufacturing (mre) review will not be performed even when product/lot information is known.Per (b)(4) it has been determined that, for the mom platform and related allegations an mre is not required.
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Search Alerts/Recalls
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