Catalog Number UNK HIP ACETABULAR CUP PINNACL |
Device Problem
Osseointegration Problem (3003)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 12/15/2020 |
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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The patient was revised to address loosening of the cup at the bone to implant interface (non-cemented).The surgeon removed the cup, liner, screws, hole eliminator, and the head.These were replaced with a stryker cup/liner and a depuy head.The summit duo fix stem was solid.The billing sheet or info on product numbers or lot numbers to document removal could not be located.Done by dr.(b)(6) in (b)(6).The original implant date was unknown.No surgical delay was noted.Doi: unknown.Dor: (b)(6) 2020; affected side: unknown.
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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.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
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Search Alerts/Recalls
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