(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 3007963827-2019-00102, 3007963827-2019-00103, 3007963827-2019-00104, and 0002648920-2019-00269.Concomitant medical devices: psn fem ps cmt ccr std sz 10 l, catalog#: 42500606801, lot#: 63983030; psn tib stm 5 deg sz g l, catalog#: 42532007901, lot#: 64075190; psn asf ps 11mm ve l 10-12 gh, catalog#: 42512401011, lot#: 64065570.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Reported event was confirmed by review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient is obese with a bmi 34.2, no intra-op complications noted, aspirin prescribed, compression stockings utilized for dvt prophylaxis, hospitalized for pulmonary embolism experienced within 2 weeks post-operation and discharged in 2 days.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to 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.
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