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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Pulmonary Embolism (1498)
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Event Date 03/12/2019 |
Event Type
Injury
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Manufacturer Narrative
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(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 all poly pat ply 35mm catalog#: 42540000035 lot#: 64291028.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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Event Description
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It was reported that patient underwent left total knee arthroplasty.Subsequently, the patient experienced a pulmonary embolism eleven days after the procedure, which required hospitalization.No revision procedure has been reported.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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