Outcomes Study of the TM Reverse Shoulder System Used in Primary or Revision Reverse Total Shoulder Arthroplasty

The objectives of this study are to obtain survival and outcome data on the Trabecular Metal
Reverse Shoulder System when used in primary or revision reverse total 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 Reverse Shoulder System.

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 Reverse Shoulder System.

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 analysis
of x-rays.

Inclusion Criteria:

- Patient is > 18 years of age;

- Patient is skeletally mature;

- Patient qualifies for primary or revision unilateral or bilateral reverse total
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, gross rotator cuff deficiency or failed total shoulder arthroplasty (both
glenoid and humeral components require revision);

- 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 willing 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.