(b)(4).Unique identifier (udi) #: n/a.Concomitant medical products- tibial component, catalog # 00584200202, lot # 11018158.Articular surface, catalog # 00584202208, lot # 63166546.Headed screw 48 mm, catalog # 00579104100, lot # 63369164.Headed screw 48 mm, catalog # 00579104100, lot # 63375936.Headed screw 48 mm, catalog # 00579104200, lot # 63406834.Headed screw 27 mm, catalog # 00579104300, lot # 62933162.Headed screw 33 mm, catalog # 00579104400, lot # 63316212.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation due to location of the device is unknown.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.Udi- (b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Per the unicompartmental knee package insert, pain is a known potential adverse effect of this procedure.A definitive root cause cannot 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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