It was reported that patient underwent an initial shoulder procedure on an unknown date in 2010.The patient underwent closed reduction for dislocation on an unknown date in (b)(6) 2011.Subsequently, the patient was revised on (b)(6) 2011 due to dislocation.The humeral tray and bearing were removed and replaced.Additionally, patient fell and fractured the humeral tray and was revised on (b)(6) 2015.The humeral tray and bearing 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 possible adverse effects: "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight.".
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