Catalog Number 11-301310 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Information (3190)
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Event Date 12/04/2019 |
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 device location is unknown.The investigation is in process.Once the investigation is complete, a follow ¿up mdr will be submitted.(b)(4).Concomitant medical products: item #11-301310/ arcos cone/ lot #333950.Item#11-300814 / arcos taper/ lot # 974700.Item# 11-107019/freedom const head/ lot #368920.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-05801.
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Event Description
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It was reported that patient underwent bilateral patient underwent left hip revision 7 months post implantation due to disassociation as arcos cone body spun and head came off of stem.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 due to limited information received from the customer.Device was not returned.Device history record (dhr) 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.Multiple mdr: 0001825034-2020-01559.
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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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Search Alerts/Recalls
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