(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.Concomitant medical devices: item number: 010000589, item name: comprehensive reverse baseplate, lot number: 938520; item number: 113628, item name: comprehensive reverse primary stem, lot number: 006290; item number: 115310, item name: comprehensive reverse glenosphere, lot number: 067680; item number: 115395, item name: comprehensive reverse central screw, lot number: 939230; item number: 180550, item name: comprehensive locking screw, lot number: 529360; item number: 180551, item name: comprehensive locking screw, lot number: 641150; item number: 180553, item name: comprehensive locking screw, lot number: 712570; item number: 110031402, item name: mini tray, lot number: 64361090.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2020 - 03891.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of medical records noting pain, instability and decreased range of motion.Dhr was reviewed and no discrepancies were found.The root cause is 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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