Exactech Shoulder Post Market Clinical Follow-up Study

The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.

Inclusion Criteria:Patient is indicated for shoulder arthroplasty (or has previously undergone shoulder arthroplasty)Patient is at least 21 years of agePatient is expected to survive at least 2 years beyond surgeryPatient is willing to participate by complying with pre- and postoperative visit requirementsPatient is willing and able to read and sign a study informed consent formExclusion Criteria:Osteomyelitis of the proximal humerus or scapula; if a systemic infection or a secondary remote infection is suspected or confirmed, implantation should be delayed until infection is resolvedInadequate or malformed bone that precludes adequate support or fixation of the prosthesisMedial humeral bone loss resulting in compromised humeral stem fixationProximal humeral bone loss extending distal to the surgical neck where there is compromised humeral stem fixationNeuromuscular disorders that do not allow control of the jointSignificant injury to the brachial plexusNon-functional deltoid musclesPatient's age, weight, or activity level would cause the surgeon to expect early failure of the systemThe patient is unwilling or unable to comply with the post-operative care instructionsAlcohol, drug, or other subtance abuseAny disease state that could adversaly affect the function or longevity of the implantPatient is pregnantPatient is a prisonerPatient is contraindicated for the surgeryRevision cases in which a stemmed humeral component was used (Stemless Shoulder System)Metal allergy or sensitivity to the implants materials (Stemless Shoulder System)Acute fracture of the proximal humerus and displacement of the tuberosities, displaced three or four part fractures of the proximal humerus (hemi-arthroplasty), or acture fracture of the proximal humerus with failure of the glenohumeral joint (total anatomic shoulder arthroplasty) (Stemless Shoulder System)Acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty) (Stemless Shoulder System)