(b)(4).Concomitant medical products: catalog number: 00625006535, lot number:64190171, brand name: bone screw; catalog number:00771100910, lot number: 63994695, brand name: m/l taper stem; catalog number: 00877502802, lot number: 2960402, brand name: biolox delta ceramic head; catalog number: 010000661, lot number:3442540, brand name: g7 acetabular shell; catalog number:110024461, lot number:599730, brand name: g7 dual mobility; catalog number:xl-200144, lot number: 332220, brand name: act artic hd arcom.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2019-00380, 0001822565-2019-02254.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 remains implanted in the patient.
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This follow-up report is being submitted to relay additional information.The following sections were medical records were provided and reviewed by a health care professional.Review of the available records identified that the patient underwent hospitalization and a cardiac catheterization due to myocardial infarction.Mild myocardial infarction, nausea and vomiting, per a patient report, records are limited.3 nights hospitalization, fluids and electrolytes, elective cardiac catheterization.Reported event was confirmed by review of medical records provided.Device history record 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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