Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Naturally Worn (2988)
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Patient Problems
Tissue Damage (2104); Test Result (2695); No Code Available (3191)
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Event Date 01/01/2019 |
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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Literature article entitled: "outcomes of a metal-on-metal total hip replacement system" the study analyzed the outcomes of metal on metal thr systems involving the corail stem, pinnacle cup, ultramet liner, and articuleze femoral head.578 uncemented hips were followed in the study.39 hips from 38 patients were revised within a mean time of 3.5 years.They were identified by age/gender.Patient #36 is a (b)(6) old female revised for adverse reaction to metal debris.Elevated cocr blood metal ions were noted prior to revision.The head and liner was revised.Intraoperative findings include black/grey fluid with metallosis.
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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.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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