Model Number N/A |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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Cmp-(b)(4).The investigation is still 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 that a patient is being considered for a revision surgery.No revision procedure has been reported to date.The revision will be due to a badly deformed acetabulum and needs a custom implant created for patient.Attempts have been made and no further information has been provided to date.
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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 as part number / lot number of device involved in the incident is unknown.Dhr review was unable to be performed as the lot number of the device involved in the 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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