Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer 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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Event Description
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It was reported patient underwent a tsa and during the procedure a post of the trial broke.After preparing for the glenoid, the surgeon impacted the modular hybrid glenoid base and regenerex trial and determined it was ready for implantation.When he removed the glenoid trial, the inferior right peripheral post broke off the trial and was in the patient's glenoid.He was able to remove the peripheral peg by drilling into it using the hybrid glenoid straight shank drill and pulling the peg out.Then he proceeded as normal.
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Manufacturer Narrative
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(b)(4).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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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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(b)(4).Reported event was confirmed as visual examination of the returned product found that the post was fractured and the device had signs of repeated use.Also, the sem analysis found that surface artifacts of the fracture site suggest an overload fracture.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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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