As reported, approximately 6 mos postop the initial l tsa, this patient presented and describes two prolonged subluxation and instability events that both self-reduced.The procedure was completed in outpatient surgery.The patient was revised, and the event was reported as resolved on (b)(6) 2021.The case report form indicates this event is unlikely related to devices and possibly related to procedure.This event report was received through clinical data collection activities.
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(h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the dislocation and subsequent closed reduction cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and the result of loosened supporting ligaments and muscles, which allowed for dislocation occurring due to the significant ligament reconstruction.
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