Device Dossier

RSP Monoblock Revision Humeral Stem - Uncoated shoulder humeral stem prosthesis

Device Dossier for RSP Monoblock Revision Humeral Stem - Uncoated shoulder humeral stem prosthesis (Uncoated shoulder humeral stem prosthesis, Class III,…

Intended purpose

The Reverse® Shoulder Prosthesis Monoblock is indicated for patients with a functional deltoid muscle with a grossly deficient rotator cuff shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff shoulder joint: • In cases of fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder, including humeral head fracture or displaced 3- or 4-part fractures of proximal humerus. • In cases of bone defect in proximal humerus. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s). The glenoid baseplate is intended for cementless application with the addition of screws for fixation. The humeral stem is intended for cemented or cementless use.

Functional description

The Revision RSP Monoblock humeral stem incorporates the socket as a one piece device and is manufactured from wrought titanium. The stem portion has a straight cylindrical distal stem and a conical body. The neck angle is 135 degrees. The socket portion retains the same design as the Modular RSP Socket and can be combined with any socket insert. It is for use in patients with non-functional rotator cuffs. The design is ‘inverted’.

TGA Public Summary