It was reported that a patient underwent a univers revers total shoulder procedure (b)(6) 2019.The patient was experiencing post op pain and an infection.The original surgeon performed a second surgery at the same facility (b)(6) 2020.During the second surgery the following original arthrex products were explanted: ar-9501-06p, univers revers stem, lot 18.01910, ar-9502f-42cpc, univers revers suture cup, lot 170095605, ar-9502-42arca, revers adapter assembly, lot 241624, ar-9556-22rca, revers ca humeral head, lot 10165385.The explanted devices will be returned for evaluation.Additional information obtained 07/22/2020: the glenoid implants from the original procedure were left in the patient.The only devices explanted were the above listed implants.The specific type of infection or any culture results are not being provided to the sales rep.
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