Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/29/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The 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 during a knee arthroplasty, the articular surface could not be implanted after numerous attempts.The device was deemed too deformed to implant and another device was used to complete the procedure.No adverse events were reported as a result of this malfunction.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the returned articular surface showed signs of use and the dovetail feature was flared out.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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