A Clinical Investigation of the Discovery™ Elbow System

Patient follow-up outcomes measured by the ASES score, radiographs and adverse
events/revisions.

Inclusion Criteria:

- Non-inflammatory degenerative joint disease including osteoarthritis and avascular
necrosis.

- Inflammatory arthritis

- Revision where other devices or treatments have failed

- Correction of functional deformity

- Treatment of acute fractures or non-union about the elbow

Patient Selection factors to be considered include:

- Need to obtain pain relief and improve function.

- Ability and willingness to follow instructions including control of weight and
activity levels.

- Patients who are able and willing to return for follow-up evaluations.

- Patients with a good nutritional state.

- Patients with full skeletal maturity.

- Patients of all races and gender.

- Patients who are able to follow care instructions.

Exclusion Criteria:

- Patients less than 18 years.

- Patients with marked bone loss which would preclude proper fixation of the
prosthesis.

- Metabolic disorders, which may impair bone formation.

- Patients who are pregnant.

- Patients with an active or suspected infection in or around the elbow or distant foci
of infections, which may spread to the implant site.

- Patients with a highly communicable disease or diseases that may limit follow-up
(e.g. immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic
disease, etc.).

- Patients unwilling or unable to comply with a rehabilitation program for elbow
replacement or who indicate difficulty or inability to return for follow-up visits
prescribed by the study protocol.

- Patients who qualify for inclusion in the study, but refuse consent to participate in
the study.