Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 09/06/2018 |
Event Type
Injury
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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 has been reported that during surgery, the tip on the glenoid trial broke while doctor was trialing.The broken piece was retrieved from the patient's body upon trial completion.No additional patient consequences were reported.
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Event Description
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It has been reported that during surgery, the tip on the glenoid trial broke while doctor was trialing.The broken piece was retrieved from the patient's body upon trial completion.No additional patient consequences were reported.
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Manufacturer Narrative
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(b)(4).Reported event was confirmed by review of products returned.Visual inspection showed wear and tear marks from use on the glenoid.Fracture of the central post was confirmed.Dhr was reviewed and no discrepancies relevant to the reported event 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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