(b)(4).Concomitant medical products: 00434903603, poly liner plus 3 mm, 62471628; 00434903611, glenosphere 36 mm diameter, 62540042; 00434901500, base plate 15 mm post, 62541526.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-03682, 0001822565-2019-03683, 0001822565-2019-03684.
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Reported event was confirmed by review of medical records.Device history record (dhr) was reviewed and no discrepancies were found.Review of provided ct scan identified chronic ununited fracture of the acromion process with inferiorly displace fracture fragment narrowing the subacromial space.Fracture of acromion of scapula, right, sequela.A definitive root cause cannot 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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