Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Fracture, Arm (2351)
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Event Date 08/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product's 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 location is unknown.
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Event Description
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It was reported that bilateral patient underwent right reverse shoulder arthroplasty approximately 8 years ago.Subsequently, the patient underwent a revision procedure about 3 months ago due to fractured humeral tray.During the procedure they were unable to remove the stem and broke the patient's arm to get it out.
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Manufacturer Narrative
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(b)(4).Reported event was considered confirmed as the medical records stated that the trunnion from the humeral tray had broken.The stem was removed due to the trunnion fracture however is was well fixed and during removal the proximal humerus fractured.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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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).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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Manufacturer Narrative
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Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate (b)(4).Event will be captured within mfr number 0001825034-2022-00452.
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Event Description
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Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate (b)(4).Event will be captured within mfr number 0001825034-2022-00452.
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Search Alerts/Recalls
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