Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
No Code Available (3191)
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Event Date 07/21/2020 |
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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It was reported that surgeon elected to perform a revision surgery.Cemented femoral stem component was revised due to loosening at cement to implant interface, the poly liner was exchanged as well.Ref and lots were illegible.Original implant date unknown.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.Patient code: no code available (3191) is used to capture insufficient information.
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Search Alerts/Recalls
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