Catalog Number UNK-HIP |
Device Problems
Disassembly (1168); Metal Shedding Debris (1804)
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Patient Problem
No Information (3190)
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Event Date 09/25/2006 |
Event Type
Injury
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Event Description
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Pfs and medical records received.Patient was revised on (b)(6) 2006 for a dislodgment of the liner.Dislocation, synovitis, and metallic debris was also noted.The femoral head was noted to be riding in the cup.
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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.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.Udi: unavailable.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible for the unknown lot code(s).Corrective action was not indicated.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.
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Search Alerts/Recalls
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