PRIMA Stem Surgical technique
Indications, Contraindications, Warnings and Risk Factors
Contraindications Absolute contraindications include: • local or systemic general infection; • septicaemia; • persistent acute or chronic local or systemic osteomyelitis; • confirmed neurologic lesion compromising shoulder joint function; • in case of reverse prosthesis, deltoid muscle insufficiency; • poor bone stock compromising stability
Warnings
Consult instruction for use provided in the product package
In selecting patients for surgery, the following factors can be critical to the eventual success of the procedure: • Partial Shoulder replacement : in cases of a deficient and unreconstructable rotator cuff, a CTA-head is indicated; • Total Shoulder replacement : the rotator cuff must be functional, intact or reconstructable. In cases of a deficient and unreconstructable rotator cuff, a hemiprosthesis with a CTA head or a Reverse Total Shoulder Arthroplasty is indicated; • Reverse Shoulder replacement : the bone stock of the glenoid and humerus must be able to support the implant. In cases of significant bone loss or in which adequate
of the implant (severe fracture of the proximal humerus, meta- epiphyseal pseudoarthrosis, osteoporosis,
osteomalacia, extended bone loss after previous prosthetic or non-prosthetic surgery); • tumor; • serious muscular, neurological, or vascular diseases compromising stability of the implant. Relative contraindications include: • proximal humerus fracture sequelae with inadequate bone stock; • vascular or nerve diseases affecting the concerned limb; • metabolic disorders which may impair fixation and stability of the implant; • any concomitant disease that might affect the implanted prosthesis; • metal hypersensitivity to implant materials (CoCrMo); • patient with significant renal impairment.
fixation on the glenoid side cannot be obtained, a hemiarthroplasty with a CTA- head should be performed.
Note. For SMR Shoulder System components refer to the proper Instructions for Use leaflet.
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