Catalog Number UNK-HIP |
Device Problems
Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)
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Patient Problems
Irritation (1941); Pain (1994); Discomfort (2330)
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Event Date 05/25/2016 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.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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On (b)(6) 2017: litigation received.Litigation alleges friction and wear between the cobalt-chromium metal head and liner caused large amounts of toxic cobalt-chromium metal ions.As a result patient experienced severe pain, discomfort and inflammation in and around the implant.
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Manufacturer Narrative
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No device associated with this report was received for examination.Depuy considers the investigation closed.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 will be filed as appropriate.
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Search Alerts/Recalls
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