Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Fall (1848); Bone Fracture(s) (1870); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 07/27/2020 |
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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The patient was revised due to fall resulted to a fractured femur and loosening of the femoral stem at the implant to bone interface.The femoral stem (summit 9 std) was removed and replaced.Doi: 2016, dor: (b)(6) 2020, left hip.
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Manufacturer Narrative
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Product complaint # (b)(4).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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