Model Number N/A |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown-unk broach- 595880.X31-400038-exact alliance tpr rmr 18mm-239510.110010246-g7 osseoti 4 hole shell 56mm f-6528677.30124006-g7 vit e high wall lnr 40mm f-64552361.010001036-cocr fem hd 40mm type1 -3mm-6553180.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.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 during an initial hip procedure that the femoral stem would not seat properly with the broach.During the procedure the surgeon chose to use -3 head from the original std head.Stem was implanted and sat proud.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Root cause was unable to 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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Event Description
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No additional information on the reported event.
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Search Alerts/Recalls
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