Model Number N/A |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Code Available (3191)
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Event Date 08/10/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 mdr will be submitted.Discarded.
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Event Description
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It was reported that a patient underwent a revision procedure approximately two years post-implantation due to disassociation.The poly dissociated from the stem.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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Reported event was unable to be confirmed due to limited information received from the customer.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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Search Alerts/Recalls
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