Model Number N/A |
Device Problem
Fitting Problem (2183)
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Patient Problem
No Information (3190)
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Event Date 05/10/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical device: udi # n/a.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Device evaluated by manufacturer? not returned to manufacturer.
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Event Description
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It has been reported that during surgery, the stem did not provide proper fixation.Therefore, the surgeon had to remove the implant and ream up a size.Surgery was completed with a larger size implant.No additional patient consequences were reported.
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Manufacturer Narrative
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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.
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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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