OsseoFit Stemless Shoulder System (Anatomic)

Exclusion Criteria

• •Patient is unwilling or unable to give consent or to comply with the follow-up program.
• •Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.
• •Patient is known to be pregnant or breastfeeding.
• •Patient is a vulnerable participant (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non-compliant).
• •Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.
• •Patient has any neuromuscular disease compromising the affected limb.
• •Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site. This may include:
• •* Local/systemic infection
• •* Sepsis
• •* Osteomyelitis
• •Patient presents with Osteomalacia.
• •Patient presents with a humeral bone fracture.
• •Patient presents with malunion or non-union of the tuberosities of the proximal humerus.
• •Patient has had a previous operative shoulder prosthesis (stem or stemless).
• •Patient has irreparable cuff tear.
• •Patient presents with inadequate humeral bone, which in the opinion of the Investigator, may lead to poor implant fixation. This may include but is not limited to:
• •* Osteoporosis
• •* Extensive Avascular Necrosis
• •* Rheumatoid Arthritis
• •* Metaphyseal bony defects (including large cysts)