(b)(4).Attempts have been made and additional information on the reported event is unavailable at this time.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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: 0001822565-2018-03625, 0001822565-2018-03627.
|
(b)(4).Concomitant medical products - femoral size g, lt part # 00596401751, lot # 62254530, tibial plate, size 8 (blue/str blue) part # 00598005702, lot # 62133498, all-poly patella, 38mm x 9.5mm part# 00597206538, lot# 62413073, refobacin bone cement r part # 3003940002 lot # 235bae2108.Report source foreign - (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.No devices were received; therefore, the condition of the components is unknown.Surgical notes were not provided.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.However, 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.
|