(b)(4).Customer has not indicated whether or not the product will be returned to zimmer biomet for investigation, as the device remains implanted at this time.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: 0001825034-2017-02810, 02812, 02813, 02814, and 02816.
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It was reported that the patient underwent an initial left total shoulder arthroplasty.Subsequently, the patient had supraspinatus atrophy noted at six (6) week post-operative follow-up.Additionally, anterior instability was noted at three (3) month post-operative follow-up, however was resolved by one year post-operative follow-up.Glenoid radiolucency was additionally noted at one year post-operative follow-up.The condition remains tolerated.No additional patient consequences reported.
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