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

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

johnson & johnson medical pty ltd t/a depuy synthes - 48088 - humeral head prosthesis - the global ap 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 or a glenoid fossa prosthesis as part of a shoulder replacement. eccentric heads accommodate patients with off-centre proximal humerus. the global ap 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. u

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 unite epiphysis (body) is manufactured out of titanium and has a porocoat coating . the global unite body is a modular component that connects to both the global unite stem and global unite humeral head. the modular proximal bodies allow the surgeon to restore joint height in press-fit and cemented applications. the global unite body (epiphyseal) is one component of the global unite reverse shoulder system and intended for press-fit or cemented 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

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 unite revision stem is manufactured from titanium and coated in porocoat (titanium sintered beads) to allow biological fixation. the global unite revision stem affixes to the global unite body. the global unite revision stem is one component of the global unite reverse shoulder system and intended for press-fit or cemented 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

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 unite stem is manufactured from titanium and coated in porocoat. the global unite stem affixes to the global unite body. the global unite stem is one component of the global unite reverse shoulder system and intended for cemented or uncemented 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

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

johnson & johnson medical pty ltd t/a depuy synthes - 48090 - press-fit 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 for: 1. ununited humeral head fractures. 2. avascular necrosis of the humeral head. 3. rotator cuff tear arthropathy.

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

johnson & johnson medical pty ltd t/a depuy synthes - 48090 - press-fit 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 is also indicated for: 1. ununited humeral head fractures. 2. avascular necrosis of the humeral head. 3. rotator cuff tear arthropathy.