The purpose of this clinical investigation is to establish the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty. Safety and efficacy of the device will be measured by collection and analysis of the following data at the two-year or greater time point (22 months post-operative or longer):~American Shoulder and Elbow Surgeons (ASES) Score~Single Assessment Numeric Evaluation (SANE)~Constant Score~Radiographic assessment of osteolysis, radiolucencies, migration, and subsidence~Comparison of overall adverse event rates including rates of removal/revision and other serious adverse events.
The purpose of this clinical study is to determine the safety and efficacy of the Comprehensive® Shoulder System with Nano Humeral Component in Total Shoulder Arthroplasty (TSA).