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 12/14/2021 |
Event Type
malfunction
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Event Description
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It was reported that during knee arthroplasty the surgeon was not able to seat the articular surface on the tibial component after attempting several times.Another articular surface 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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(b)(4).Foreign: (b)(6).The complainant has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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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 (nicked/gouged) and the dovetail feature was flared.The device history records were reviewed and no discrepancies were identified.The damage seen on the dovetail confirms the implant would not have been able to seat, however, 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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