Zimmer biomet complaint:(b)(4).This report is being submitted late as it has been identified in remediation.Complaint sample was evaluated and the reported event was not confirmed.As per investigation, complaint is unconfirmed as review of the manufacturing history records show the parts left zimmer biomet conforming.The root cause cannot currently be determined.Dhr was reviewed and no discrepancies were found.Device analysis indicated that the device met specification.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2015-05196, 0001825034-2015-05196-1, 0001825034-2015-05196-2, 0001825034-2015-05196-3, 0001825034-2015-05195, 0001825034-2015-05195-1, 0001825034-2015-05195-2, 0001825034-2015-05195-3.
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It was reported a patient underwent an initial total hip arthroplasty, during the procedure, two liners would not seat into the cup, causing a thirty minute delay.Another cup and liner was used to complete the procedure.No additional patient consequences were reported.
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