It was reported that the patient had undergone an initial revision surgery on (b)(6) 2018 during which the following devices were implanted: ar-9120-01 (lot 170115215), ar-9145-36 (lot 170037012), ar-9145-30 (lot 170057712), ar-9504s-04 (lot 170091414), ar-9555-09 (lot 2501367202), ar-9503s-03c (lot 2501374603), ar-9165-25 (lot 2501357504).The (b)(6) 2018 procedure was a revision of arthrex products because the patient had glenoid instability due to baseplate placement on the primary.It is unknown if the 2018 revision was ever reported to arthrex as no details from the original surgery are known to search/match part numbers.The implants put in on (b)(6) 2018 were done so in a compromised glenoid with poor bone quality.The peripheral screws broke and led to baseplate failure.The glenosphere remained engaged in the baseplate.There was significant corrosion of the humeral poly insert.The glenoid components failed nearly two years ago but the patient waited until (b)(6) 2020 to have a revision surgery.The sales representative reported that the surgeon attributed the failure to putting the baseplate on her original reverse procedure too superior on the face of the glenoid with significant superior tilt.Pictures were provided to arthrex.Explanted devices will not be returned for evaluation because the parts are being analyzed by the hospital for infection.
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