Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 36259 - prosthesis, internal, joint, shoulder, glenoid component - the global glenoid crosslinked anchor peg is made of crosslinked polyethylene and implantation is intended to be performed with bone cement and bone paste. the global glenoid crosslinked anchor peg achieves immediate stability with the three minimally cemented peripheral pegs, and provides fixation through an interference fit of the central peg. the central peg facilitates bony integration around the flutes for increased fixation strength. the global glenoid crosslinked anchor peg is the glenoid component of a total shoulder joint prosthesis. total shoulder replacement is indicated for: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon?s experience indicates that alternative methods of treatment are unsatisfactory. 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 36259 - prosthesis, internal, joint, shoulder, glenoid component - the global shoulder glenoid peg is affixed to the glenoid cavity bone to replace or repair the articulating surface. the device is made of enduron polyethylene and implantation is intended to be performed with bone cement. five pegs (one central and four peripheral) provides stability for the component. the global shoulder glenoid peg is the glenoid component of a total shoulder joint replacement. total shoulder shoulder replacement is indicated for: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon?s experience indicates that alternative methods of treatment are unsatisfactory. 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 36259 - prosthesis, internal, joint, shoulder, glenoid component - the global glenoid crosslinked fin is is affixed to the glenoid cavity bone to replace or repair the articulating surface. the device is made of moderately cross-linked polyethylene and implantation is intended to be performed with bone cement and bone paste. the global glenoid crosslinked fin is the glenoid component of total shoulder joint replacement. total shoulder replacement is indicated for: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon?s experience indicates that alternative methods of treatment are unsatisfactory. 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component).

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 39702 - coated shoulder humeral stem prosthesis - the global fx porocoat stem is made of cocr and is coated with porocoat (titanium sintered beads) intended to improve fixation and stability by promoting bone ingrowth. global fx can be used for cemented or cementless applications. global fx provides fixation within the proximal humerus and a site of attachment for a humeral head. the global fx porocoat stem is one component of total or hemi shoulder joint replacement. total shoulder or hemi-shoulder replacement is indicated for: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon?s experience indicates that alternative methods of treatment are unsatisfactory. 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component). hemi-shoulder replacement i

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 48089 - humeral head resurfacing prosthesis - the global cap head duofix ha pc is made from cocr with its underside coated in duofix (combination of sintered titanium metal beads and hydroxyapatite) for cementless fixation. the global cap head duofix re-surfaces the humeral head and articulates with either an implanted glenoid component or without a glenoid (hemiarthroplasty). the global cap head duofix ha pc resurfaces the humeral head duing total or hemi-shoulder arthroplasty and is indicated for: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon?s experience indicates that alternative methods of treatment are unsatisfactory. 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component). 4. ununited humeral head fractures. 5. avascular necro

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 39702 - coated shoulder humeral stem prosthesis - the global ap porocoat humeral stem is made of titanium and is either cemented or cementless. it is coated with porocoat which is intended to improve fixation and stability by promoting bone ingrowth. the global ap porocoat humeral stem is designed to provide fixation within the proximal humerus and a site of attachment for a humeral head prosthesis. the global ap porocoat humeral stem is the humeral component of a total or hemi shoulder joint replacement. total shoulder or hemi-shoulder replacement is indicated for: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon?s experience indicates that alternative methods of treatment are unsatisfactory. 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component). hemi-shoulder replacement is also indicated for: 1. ununited humeral head fractures. 2. avascular necrosis of the humeral head. 3. rotator cuff tear arthropathy. 4. deformity and/or limited motion.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 34197 - uncoated shoulder humeral stem prosthesis - the global fx humeral stem is made of cobalt chrome, uncoated and implantation is intended to be performed with bone cement or impaction bone grafting. it is designed to provide fixation within the proximal humerus and a site of attachment for a humeral head prosthesis as part of a shoulder joint replacement global fx humeral stem is the humeral component of a total or hemi shoulder joint replacement. total shoulder or hemi-shoulder replacement is indicated for: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon?s experience indicates that alternative methods of treatment are unsatisfactory. 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component). hemi-shoulder replacement is also indicated f

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 48088 - humeral head prosthesis - the global advantage humeral head is made of cobalt chrome and designed to be attached to a humeral stem prosthesis and to articulate with the natural glenoid fossa, a glenoid fossa prosthesis as part of a shoulder replacement. eccentric heads accomodate patients with off-centre proximal humerus. the global advantage humeral head is the humeral head component of a total or hemi shoulder joint replacement. total shoulder or hemi-shoulder replacement is indicated for: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon?s experience indicates that alternative methods of treatment are unsatisfactory. 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component). hemi-shoulder replacement is also indicated for: 1. ununited humeral head fractures. 2. avascular necrosis of the humeral head. 3. rotator cuff tear arthropathy. 4. deformity and/or limited motion.

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 34197 - uncoated shoulder humeral stem prosthesis - the global advantage humeral stem is made of titanium and implantation is intended to be performed with bone cement, press fit or impaction by bone grafting. it is designed to provide fixation within the proximal humerus and a site of attachment for a humeral head prosthesis as part of a shoulder joint replacement. the global advantage humeral stem is the humeral component of a total or hemi shoulder joint replacement. total shoulder or hemi-shoulder replacement is indicated for: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon?s experience indicates that alternative methods of treatment are unsatisfactory. 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component). hemi-shoulder replacement

Australia - English - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 48088 - humeral head prosthesis - the global unite humeral head is manufactured from cocr and affixes to the the stem of the global unite proximal body and articulates with the humeral cup. eccentric heads accomodate patients with off-centre proximal humerus. the global unite humeral head is one component of the global unite reverse shoulder system and intended for total shoulder or hemi-shoulder replacement in treatment of the following: 1. a severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis 2. fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon?s experience indicates that alternative methods of treatment are unsatisfactory 3. other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component) hemi-shoulder replacement is also indicated for: 1. ununited humeral head fractures 2. avascular necrosis of the humeral head 3. deformity and/or limited motion