(b)(4).Concomitant medical products: catalog #: 42532007102, tibia cemented 5 degree stemmed right size e, lot # 63490887, catalog #: unknown, persona femorals, lot # unknown.Reported event was unable to be confirmed due to limited information received from the customer.Device history record review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.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: 3007963827-2019-00007, 0001822565-2019-03980, 0001822565-2019-03981.
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