Outcomes Study of the TM Humeral Stem Used in Primary, Total or Hemi Shoulder Arthroplasty

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal
Humeral Stem when used in primary, total or hemi shoulder arthroplasty. This will be done by
analysis of standard scoring systems, radiographs and adverse event records. Data will be
collected and analyzed to monitor pain, function, and survivorship and to confirm the
performance of the Trabecular Metal Humeral Stem.

Performance will be evaluated by monitoring the frequency and incidence of adverse events as
well as by assessment of the overall pain and functional performances, survivorship, health
status and radiographic parameters of all enrolled study subjects who receive the Trabecular
Metal Humeral Stem.

Pain and functional performance will be measured using the American Shoulder and Elbow
Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE),
survivorship will be based on removal or intended removal of the device, health status will
be determined by evaluation of the SF-12 as well as AEs and radiographic parameters by
analysis of x-rays.

Inclusion Criteria:

- Patient is >18 years of age;

- Patient is skeletally mature;

- Patient qualifies for primary unilateral or bilateral total or hemi shoulder
arthroplasty based on physical exam and medical history including the following:
Osteoarthritis, Rheumatoid arthritis, Post-traumatic arthritis, Ununited humeral head
fracture, Irreducible 3- and 4-part proximal humeral fractures, Avascular necrosis

- Patient is willing and able to provide written informed consent;

- Patient is willing and able to cooperate in the required post-operative therapy;

- Patient is will and able to complete scheduled follow-up evaluations/questionnaires as
described in the Informed Consent;

- Patient has participated in the Informed Consent process and has signed the IRB/ERB
approved informed consent;

Exclusion Criteria:

- The patient is a prisoner;

- The patient is mentally incompetent or unable to understand what participation in the
study entails;

- The patient is a known alcohol or drug abuser;

- The patient is anticipated to be non-compliant;

- The patient has one of the following compromising the affected limb; a significant
injury to the upper brachial plexus, paralysis of the axillary nerve or a
neuromuscular disease compromising the affected limb which would render the procedure
unjustifiable;

- The patient has a local/systemic infection;

- The patient is known to be pregnant;

- The patient has marked bone loss;

- The patient has a known sensitivity or allergic reaction to one or more of the
implanted materials;

- The patient is unwilling or unable to give consent or to comply with the follow-up
program.