Catalog Number UNK-ASR |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Inflammation (1932); Pain (1994); Joint Swelling (2356)
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Event Date 01/03/2015 |
Event Type
Injury
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Manufacturer Narrative
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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No 510# number provided because this implant is sold internationally with different indications for use; it is currently sold in the us under a different part number.
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Event Description
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Jul 20, 2017: translation of litigation received.Litigation alleges pain, tumor-like mass, abnormal swelling in leg, increased chromium and cobalt levels and metallosis.
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Manufacturer Narrative
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The reported event has been evaluated and will be monitored.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 will be filed as appropriate.
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Search Alerts/Recalls
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