Catalog Number L98016 |
Device Problems
Migration or Expulsion of Device (1395); Loss of Osseointegration (2408)
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Patient Problem
No Information (3190)
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Event Date 12/13/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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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Patient was revised to address femoral stem loosening and subsidence.
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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.Corrective action was not indicated.Depuy considers the investigation closed.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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