(b)(4).Concomitant medical products: catalog number:00625006525 lot number:64175215 brand name: bone screw, catalog number: 00877502801 lot number: 2907334 brand name: biolox head, catalog number:0100102219 lot number:2937791 brand name: wagner stem, catalog number:110024463 lot number: 772480 brand name: g7 dual mobility liner, catalog number:110010244 lot number:6362614 brand name: g7 shell, catalog number:xl-200148 lot number:140080 brand name: arcom xl head.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00701.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device not returned for evaluation.
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It was reported that a patient underwent revision of left total hip arthroplasty for implant failure.Subsequently the patient was diagnosed and treated for nstemi postoperative after two days, which delayed the patients discharge.Also approximately 2 weeks post discharge experienced an isolated episode of hypertension that required an emergency room visit.Additional information was requested, however none was available at this time.
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Reported event was confirmed by review of medical records which indicated patient was diagnosed and treated for nstemi postoperative, which delayed the patients discharge.Approximately 2 weeks post discharge patient experienced an isolated episode of hypertension that required an emergency room visit.Patient was treated and released.Device history record (dhr) was reviewed and no discrepancies 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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