(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.Concomitant medical products: natural tibia trabecular metal two-peg porous fixed bearing, catalog # 42530007102, lot # 62842446.Articular surface medial congruent (mc), catalog # 42522100710, lot # 63999177.All poly patella cemented, catalog # 42540000032, lot # 64239742.The event was initially reported on 0001822565-2019-01465.Multiple mdr reports were filed for this event; please see associated reports: 0001822565-2019-01466.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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(b)(4).This follow-up report is being submitted to relay additional information.Concomitant medical products: item # 42522100710, lot # 63999177, item # 42540000032, lot # 64239742, item # 42502606001, lot # 63964206, item # 42512100710, lot # 64161945, item # 42530007101, lot # 62925430, item # 42540000032, lot # 64181002.Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00347, 0002648920-2019-00893, 3007963827-2019-00348, 3007963827-2019-00349, 0001822565-2019-05234, 0002648920-2019-00894.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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