Model Number N/A |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Information (3190)
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Event Date 09/14/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Foreign: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed.A follow-up report will be submitted.
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Event Description
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It was reported that the product did not have a tight press fit.A different implant was used to complete the procedure.
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Manufacturer Narrative
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Device history record was reviewed and no discrepancies 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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