Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); No Code Available (3191)
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Event Date 08/18/2020 |
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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A patient presented with a build up of inflammatory tissue around their previous total hip replacement.The surgeon was concerned it may be tumor and/or infection.The patient had a previous metal on metal hip using summit/pinnacle from the early 2000s and was revised to a poly liner with a ceramic biolox delta ts femoral head in 2019.In this surgery, the surgeon removed all of the "inflammatory tissue" and revised the femoral head to a longer head (36mm+12).No information regarding product numbers and/or lot numbers was provided and the hospital is not providing that information at this time.
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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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