Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Unspecified Infection (1930); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 10/27/2020 |
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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It was reported that there was a removal of total hip construct and placement of antibiotic spacer due to the presence of infection.It was also stated there was loosening of the femoral stem at the bone to implant interface.Doi: unknown, dor: (b)(6) 2020, 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.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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