Comprehensive SRS Regenerex Tissue Attachment

Inclusion Criteria:

• Patient must be 18 years of age or older.

• Patient must be willing and able to follow directions.

• The Comprehensive Segmental Revision System was used in cases of:

1. Non-inflammatory degenerative joint disease including osteoarthritis andavascular necrosis.

2. Revision where other devices or treatments have failed.

3. Correction of functional deformity.

4. Oncology applications including bone loss due to tumor resection.

• Proximal or total humeral replacement, for: Treatment of acute or chronic fractureswith humeral head (shoulder) involvement, which are unmanageable using othertreatment methods.

• Distal or total humeral replacement for: Treatment of acute or chronic fractureswith humeral epicondyle (elbow) involvement, which are unmanageable using othertreatment methods.

• Biomet Comprehensive Segmental Revision System was used in a reverse application inpatients whose shoulder joint has a grossly deficient rotator cuff with severearthropathy and/or previously failed shoulder joint replacement with a grosslydeficient rotator cuff for proximal humeral replacement. The patient must beanatomically and structurally suited to receive the implants and a functionaldeltoid muscle is necessary.

• The Comprehensive Segmental Revision System was used with bone cement in distalhumeral and total humeral applications.

• Regenerex Tissue Attachment Augments were used in combination with the ComprehensiveSegmental Revision System

Exclusion Criteria:

• Absolute contraindications:

• Infection

• Sepsis

• Osteomyelitis

• Patient is a prisoner

• Patient is a current alcohol or drug abuser

• Patient has a psychiatric illness or cognitive deficit that will not allow forproper informed consent

• Patient is unwilling to consent

• Relative contraindications:

• Uncooperative patient or patient with neurologic disorders who is incapable offollowing directions

• Osteoporosis

• Metabolic disorders which may impair bone formation

• Osteomalacia

• Distant foci of infections which may spread to the implant site

• Vascular insufficiency, muscular atrophy, or neuromuscular disease

• The Comprehensive Segmental Revision System was used in a reverse shoulderapplication in patients receiving radiation therapy

• The Comprehensive Segmental Revision System was used without bone cement in distalhumeral and total humeral applications.

• Regenerex Tissue Attachment Augments weren't used during the patient's surgery