(b)(4).Customer has indicated that the product will not be returned [location unknown] to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-03318, 0001825034-2017-07301, 0001825034-2017-07302, 0001825034-2017-07303, 0001825034-2017-07304, 0001825034-2017-07305, 0001825034-2017-07306, 0001825034-2017-07307, 0001825034-2017-07308, 0001825034-2017-07309, 0001825034-2017-07310, 0001825034-2017-07311, 0001825034-2017-07312, 0001825034-2017-07313, 0001825034-2017-07314.
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.Reported event was unable to be confirmed due to limited information received from the customer and no product was returned.Dhr and complaint history could not be reviewed due to the lack of information received.Root cause was unable to be determined.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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