Post-Market Clinical Follow-up Study (PMCF) Comprehensive Reverse Augmented Glenoid in Total Shoulder Arthroplasty

The Comprehensive Reverse Porous Augmented Glenoid belongs to the Comprehensive Reverse
Shoulder Arthroplasty System. It was developed to provide patients with grossly deficient
rotator cuffs with another surgical option. The aim of the Comprehensive Reverse Porous
Augmented Glenoid is to increase shoulder function while reducing pain.

A maximum of 7 sites will contribute to this study. Enrollment of 7 sites on a global scale
will allow for assessment of device consistency across different regions. Enrollment per site
will not exceed 15 shoulders. 50 implants will be included in this study with competitive
enrollment. All potential study subjects will be required to participate in the Informed
Consent process.

Inclusion Criteria:

- Patient must be 18 years of age or older.

- Patient must be anatomically and structurally suited to receive the implants and
possess a functional deltoid.

- Patient must have a grossly deficient rotator cuff with severe arthropathy and/or a
previously failed shoulder joint replacement with a grossly deficient rotator cuff.

- Patient must be able and willing to complete the protocol required follow-up.

- Patient must be able and willing to sign the Institutional Review Board/Ethics
Committee approved informed consent.

Exclusion Criteria:

- Patient is a prisoner.

- Patient is a current alcohol or drug abuser.

- Uncooperative patient or patient with neurologic disorders who is incapable or
unwilling to follow directions.

- Patient presents with osteoporosis.

- Patient has a metabolic disorder that may impair bone formation.

- Patient has osteomalacia.

- Patient has distant foci of infections which may spread to the implant site.

- Patient has rapid joint destruction, marked bone loss or bone resorption apparent on
roentgenogram.