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Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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This event has been recorded by zimmer biomet under (b)(4).The investigation is complete.This is an initial final report submission.Review of the most recent repair record determined the rpms were out of specification on the low end and there were worn components.The customer declined the repair and the device was returned unrepaired.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported that the device was sent in for pm and a repair was needed.There is no patient involvement.There was no alleged event or malfunction reported for this device when it was sent in for maintenance.At investigation, the rpms were out of specification on the low end.No adverse events were reported as a result of this malfunction.
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Search Alerts/Recalls
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