Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the extractor fractured during a knee revision procedure.No adverse events have been reported as a result of the malfunction.Attempts have been made and no further information has been provided.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product found the extractor has fractured below the radius of the hook and the trial has fractured off the stem.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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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