Catalog Number UNK HIP ACETABULAR LINER |
Device Problem
Naturally Worn (2988)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Tissue Damage (2104); No Code Available (3191)
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Event Date 09/21/2009 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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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Event Description
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Medical records received.After review of medical records, the patient was revised for right knee pain with failed total hip.Operative notes reported that the tension fascia lata which was not well develop.On further dissection there were essentially no external rotators, just some posterior capsular tissue and scar tissue.The acetabular component was examined and there was significant wear.Doi: unknown; dor: (b)(6) 2009; right 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.E3 initial reporter occupation: lawyer.
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Search Alerts/Recalls
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