PRIMA Stem Surgical technique
Indications The PRIMA Humeral System is intended for partial or total, primary or revision, shoulder joint replacement in skeletally mature patients. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The PRIMA Stem is intended for use in cementless applications. The PRIMA Anatomic implant is indicated for partial or total, primary or revision shoulder joint replacement, in patients suffering from pain and disability due to: • non-inflammatory degenerative joint disease (i.e., osteoarthritis); • inflammatory degenerative glenohumeral joint disease such as rheumatoid arthritis; • avascular necrosis of the humeral head; • cuff tear arthropathy (CTA Heads only). The PRIMA Reverse implant is indicated for primary reverse total shoulder replacement or for revision when converting an anatomic PRIMA arthroplasty to a reverse total shoulder arthroplasty (i.e., in case of cuff tear arthropathy or in a grossly rotator cuff deficiency joint with severe arthropathy).
Revision surgery with retention of the PRIMA Stem is intended as conversion surgery from anatomic to reverse, where the stem is stable, well positioned and tissue integrated. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses. The PRIMA Reverse implant is indicated for patients suffering from pain and disability due to: • rotator cuff tear arthropathy; • osteoarthritis with rotator cuff tear; • rheumatoid arthritis with rotator cuff tear; • massive irreparable rotator cuff tear. The PRIMA Humeral System consists of the following single use components: • Anatomic configuration: - stem, - adaptor for humeral heads, • Reverse configuration: - stem, - reverse insert.
System
Components
Material
A R ü ü
PRIMA Stem
Ti6Al4V 3D printed
ü
Adaptor for Humeral Heads
Ti6Al4V
ü
Reverse Insert
CoCrMo
Material Standards Ti6Al4V (ISO 5832-3 - ASTM F1472), Ti6Al4V 3D printed (ISO 5832-3) CoCrMo (ASTM F1537 and ISO 5832-12) A = Anatomic, R = Reverse
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