Device Problem
Migration (4003)
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Patient Problem
Failure of Implant (1924)
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Event Date 07/05/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-01775.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
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Event Description
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It was reported a patient underwent a hip revision approximately six weeks post implantation due to a vertical cup and broken screw.Attempts have been made and no further information is available.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.This complaint is unable to be confirmed as not product information or medical records were provided.Device history record (dhr) review was unable to be performed as the lot number of the device involved in this event is unknown.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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Search Alerts/Recalls
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