Model Number N/A |
Device Problems
Break (1069); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The client has indicated that the product is in process of being returned to zimmer biomet for an investigation.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.
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Event Description
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It was reported, that: the surgeon was trialling and when she removed it broke.She found all the pieces and made sure no pieces were left, inpatient.Delay: 5 min.Patient outcome: prolonged surgery.
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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).This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the returned product identified the trial bearing has two fractures.Both are from the slots on either side of the bearing.The bearing appears well used and has potentially been in the field for approximately 3 years and 8 months.A review of the device history records did not identify any discrepancies that would have contributed to the reported event.The device is used for treatment.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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