RSP® Prospective Multi-Center Study

Reverse shoulder arthroplasty for the treatment of rotator cuff deficiency and glenohumeral
arthritis have shown favorable outcomes in pain and function over the short and medium term.
A prospective, multi-center study on the outcomes of subjects treated with the RSP would be a
valuable addition to the literature and give important information regarding an
ever-increasing treatment option for subjects with rotator cuff deficiency. The study will
take place at multiple sites across the United States and will be managed by the DJO Surgical
Clinical Affairs Department. The study will include only subjects who meet the indications
for use criteria for the Reverse® Shoulder Prosthesis and who are candidates for total
shoulder replacement surgery.

Inclusion Criteria:

- Subject must be a candidate for a total shoulder joint replacement

- Subject must be diagnosed with one or more of the following conditions:

Irreparable rotator cuff tear with gleno-humeral arthritis; Failed rotator cuff surgery
with gleno-humeral instability or antero- superior escape; Failed shoulder replacement
surgery

- Subject has a functional deltoid muscle

- Subject's joint must be anatomically and functionally suited to receive the selected
implant

- Subject is 60 years of age or older (≥ 60 yrs of age) at time of consent

- Subject is likely to be available for all study visits

- Subject is able and willing to sign the informed consent and follow study procedures

- Subject is not pregnant

Exclusion Criteria:

- Subject has a non-functional deltoid muscle

- Subject has a mental condition(s) that may interfere with the subject's ability to
give an informed consent or willingness to fulfill the study requirements (i.e.,
severe mental retardation such that the Subject cannot understand the informed consent
process, global dementia, prior strokes that interfere with the Subject's cognitive
abilities, senile dementia, and Alzheimer's Disease)

- Subject is a prisoner

- Subject has high levels of physical activity (ex. competitive sports, heavy physical
labor)

- Subject is pregnant

- Subject has an active infection or sepsis

- Subject has loss of ligamentous structures

- Subject has a history of alcoholism or other addictions (current or past)

- Subject has muscular, neurological or vascular deficiencies which compromise the
affected extremity (i.e., Parkinson's Disease, Syringomyelia and Multiple Sclerosis,
Charcot joints)

- Subject has severe glenoid bone loss

- Subject has known materials sensitivity (to metals)

- Subject is younger than 60 years of age (< 60 years of age) at consent