Zimmer biomet complaint (b)(4).Unique identifier (udi) #: (b)(4).Concomitant medical product: biomet microfixation "2.4mm" system ht cross-drive screw, 2.7x10mm, catalog #: 91-2710, lot #: ni.Therapy date: (b)(6) 2018.Product has been received by zimmer biomet and 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 report: 0001032347-2018-00742.
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The products showed signs of use and because they were explanted in a revision due to infection, the complaint is confirmed.The instructions for use (ifu) for this product warns of the potential for complications including systemic or superficial infection.The dhr was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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