Model Number 00-4349-014-13 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 06/05/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01761, 0001822565-2023-01762 d10: 36mm vit e liner +0mm cat: 00435003600 lot: 65532361 36mm vit e liner +0mm cat: 00435003600 lot: 65585396 customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
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Event Description
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It was reported that the tm reverse poly did not impact onto stem.Subsequently, a humeral fracture occurred due to this issue.The poly was impacted onto the stem on the back table then re-implanted.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
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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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This follow-up report is being submitted to relay additional information.Proposed annex g code: mechanical (g04) - stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.The reported event is not confirmed.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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