It was reported that patient underwent a reverse total shoulder arthroplasty on (b)(6) 2015.Subsequently, patient was revised on (b)(6) 2015 due to the glenosphere disassociating from the baseplate.The glenosphere, taper adapter, humeral bearing, and humeral tray were removed and replaced.
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under warnings, number 2 states, "disassociations of modular components have been reported." this report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-02066 & 02068).
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