(b)(4).Concomitant medical products: 211218, compr srs prox bdy - lg 42 mm, 258120.Unknown, unknown glenoshpere, unknown.Unknown, unknown humeral tray, unknown.Unknown, unknown humeral bearing, unknown.Unknown, unknown baseplate, unknown.Unknown, unknown central screw, unknown.Unknown, unknown peripheral screw, unknown.(b)(6).Reported event was unable to be confirmed due to limited information received from the customer.The product was not returned for the investigation, therefore a visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the report event was not reported.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.This report is being submitted late as it has been identified in remediation.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-01436, 0001825034-2018-04090, 0001825034-2018-04091, 0001825034-2018-04092, 0001825034-2018-04093, 0001825034-2018-04094, 0001825034-2018-04095.
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It was reported that the patient underwent a right shoulder surgery due to a neck fracture.Patient underwent a surgery for debridement due to infection and septic loosening.As part of this study, the patient underwent a right shoulder revision procedure.It was reported that the patient suffered dislocation and subluxation of the prosthesis.The patient underwent hematoma evacuation and implant reduction as part of treatment.Subsequently, during a six month, one year, and three year follow-up, the patient reported being unable to open a jar, difficulty with heavy chores and recreational activities, washing back, and difficulty carrying bag and using a knife.The shoulder has caused moderately limited social life and work.Patient also noted for all three follow ups that there was no arm, shoulder, or hand pain.Attempts have been made and additional information on the reported event is unavailable.
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