Comprehensive Reverse Shoulder Data Collection

The Biomet Comprehensive Reverse Shoulder was developed to provide an additional surgical
option for patients anatomically and structurally suited to receive a reverse shoulder
arthroplasty. The aim of the Biomet Comprehensive Reverse Shoulder is to increase shoulder
function while reducing pain.

A total of 3 sites will be involved in this study. Having three clinical sites will allow for
multiple investigators to contribute to the results of the study. 175 implants will be
included into the study. All potential study subjects will be required to participate in the
Informed Consent Process.

Inclusion Criteria:

- Biomet® Comprehensive™ Reverse Shoulder products are indicated for use in patients
whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy
and/or previously failed shoulder joint replacement with a grossly deficient rotator
cuff.

- The patient must be anatomically and structurally suited to receive the implants and a
functional deltoid muscle is necessary.

- The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision
total shoulder replacement for the relief of pain and significant disability due to
gross rotator cuff deficiency.

Exclusion Criteria:

- Absolute contraindications include infection, sepsis, and osteomyelitis.

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

- Osteoporosis.

- Metabolic disorders which may impair bone formation.

- Osteomalacia.

- Distant foci of infections which may spread to the implant site.

- Rapid joint destruction, marked bone loss or bone resorption apparent on
roentgenogram.