Model Number N/A |
Device Problem
Migration (4003)
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Patient Problem
Failure of Implant (1924)
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Event Date 12/08/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown-unknown m2a mom head-unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, requested but not returned by hospital.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 patient underwent a revision surgery due to the cup migrating.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.The following sections were updated/corrected.Updated: g3; h2; h6.Reported event was unable to be confirmed.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not 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 additional information on the reported event.
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Search Alerts/Recalls
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