(b)(4).Concomitant medical products: catalog #: 42502006001, femur cemented cruciate retaining, lot # 64196777, catalog #: 42530006401, natural tibia trabecular metal two-peg, lot # 77007007, catalog #: 42512100412, articular surface medial congruent, lot # 63998720.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the patient has died.The investigation is in process.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: 3007963827-2019-00106, 0001822565-2019-01574, 3007963827-2019-00107, 0002648920-2019-00273.Remains implanted.
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It was further reported that the patient experienced abdominal pain, bloating, nausea, shortness of breath, and vomiting post-operatively day two and morning of day three.Subsequently, the patient expired on post-operative day three due to procedural related complications including deep vein thrombosis (dvt) and possible pulmonary embolism (pe).However, this was unable to be tested due to the patient condition.It was also noted that there were occlusive and non-occlusive thrombus located in the femoral vein as well as non-occlusive thrombus located in other areas.
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