Catalog Number 42530008302 |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problems
Pain (1994); No Code Available (3191)
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Event Date 11/01/2016 |
Event Type
Injury
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Manufacturer Narrative
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This report will be amended when our investigation is complete.
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Event Description
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It is reported that the patient is scheduled to undergo knee arthroplasty revision due to tibial loosening.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Concomitant medical product - persona vivacit-e highly crosslinked polyethylene articular surface fixed bearing cruciate retaining (cr) catalog# 42522000610 lot# 62351242, nexgen trabecular metal standard primary patella catalog#00587806541 lot# 61668516, persona femur trabecular metal cruciate retaining (cr) catalog# 42502806802 lot# 62447377.
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Event Description
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It was reported patient underwent a revision procedure due to tibial loosening and pain approximately 3 years post implantation.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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