Catalog Number UNK HIP FEMORAL STEM |
Device Problems
Corroded (1131); Appropriate Term/Code Not Available (3191)
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Patient Problems
Foreign Body Reaction (1868); Pain (1994); Discomfort (2330)
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Event Date 02/01/2017 |
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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Pinnacle litigation received.Litigation alleges pain, discomfort, elevated metal ions levels and difficulty around the hip.It was also reported that patient experience corrosion , friction and wear is believed to have caused amounts of toxic cobalt-chromium metal debris to be released into patients tissue surrounding.Doi: (b)(6) 2010: dor: (b)(6) 2017 (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.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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Search Alerts/Recalls
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