Model Number N/A |
Device Problem
Failure To Adhere Or Bond (1031)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The product will not be returned to zimmer biomet for analysis, as this facility keeps explanted products; however, an investigation has been initiated.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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It is reported that patient has been indicated for a left elbow revision of the humeral component due to loosening; however, no revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Additional: reported event was unable to be confirmed due to limited information received from the customer.Device history record 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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