Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Information (3190)
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Event Date 11/22/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: catalog #: 32810506302, interchangeable ulnar assembly, lot # 63694916.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as its location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Product will not be returned.
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Event Description
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It was reported the patient underwent an initial right shoulder anthroplasty subsequently, the patient was revised to disassociation of the pin seen on x-ray approximately five (5) months post implantation.No additional information is available at this time.
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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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It was further reported that the patient sustained a fall resulting in a fracture of right proximal humerus and right distal humerus.Approximately six (6) months ago.The right elbow arthroplasty & right total reverse shoulder were performed.Subsequently about 3 months ago underwent revision procedure of right elbow due to pin backed out.
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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 considered confirmed as the medical records stated that the locking pin had backed out.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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