(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Udi # (b)(4).Concomitant medical products: item # 42522100710 lot # 63999177, item # 42540000032 lot # 64239742, item # 42502606001 lot # 63964206, item # 42512100710 lot # 64161945, item # 42540000032 lot # 64181002, item # 42502606002 lot # 63977790, item # 42530007102 lot # 62842446.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00347, 0002648920-2019-00893, 3007963827-2019-00348, 3007963827-2019-00349, 0002648920-2019-00894, 3007963827-2019-00101, 0001822565-2019-01466.Complaint confirmed with crf report.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Crf report demonstrated that the patient had primary bilateral knees performed.Postoperative complication of fat embolus with secondary status epilepticus occurred.Patient was transferred to medical center for medical intervention.Reported issues are related to the procedure.No failure detected with the devices.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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