Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Naturally Worn (2988)
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Patient Problems
Inflammation (1932); Pain (1994); Discomfort (2330); Test Result (2695); No Code Available (3191)
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Event Date 11/21/2016 |
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.(b)(4).(b)(6).
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Event Description
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Litigation alleges corrosion and friction wear caused toxic cobalt- chromium metal debris to be released into patient's blood, tissue, and bone surrounding the implant.After the surgery, patient experienced severe pain,inflammation, and around the patient's implant.
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Event Description
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Updated dor and associated contact.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: no devices or product details were received.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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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