Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Numbness (2415); No Information (3190)
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Event Date 02/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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Cmp-(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-04467, 0001825034-2017-04469, 0001825034-2017-04470.Customer has indicated that the product will not be returned to zimmer biomet for investigation, devices remain implanted.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 that a patient was experiencing numbness going down their thigh approximately five months post-implantation.No revision has been reported.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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.Review of the complaint history determined that no further action is required as no trends were identified.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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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