Model Number N/A |
Device Problem
Component Incompatible (1108)
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Patient Problem
No Information (3190)
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Event Date 09/13/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 the patient was implanted with mismatched devices and as a result had to be revised.A 36mm femoral head was implanted with a 32mm liner.No further information has been made available.
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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 customer.Device history record (dhr) 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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Search Alerts/Recalls
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