(b)(4).Complaint sample was evaluated and the reported event was confirmed.All explanted devices were returned, and cement was found on the tibia, and wear on the articular surface.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Per package inserts: wear and loosening are known adverse effect of this system.The wear in the poly might cause the tibia to loose as stated in the reported event.However, sufficient information was not provided to identify the cause of the articular surface wear.Therefore, 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.Concomitant medical products: 42522200613, articular surface, lot # 63057860; 42502806802, femur, lot # 63351597.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00727.
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