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DEVICE DETAILS

NAME OF DEVICEULTAMET FEMORAL HEAD
ESTABLISHMENT NAMEJOHNSON & JOHNSON SDN BHD
REGISTRATION NOGC18716509217
BRAND NAMEULTAMET
DESCRIPTIONDEPUY ULTAMET FEMORAL HEADS ARE CO-CR-MO ALLOY FEMORAL HEADS AVAILABLE IN A RANGE OF SIZES AND NECK LENGTHS. A DEPUY ULTAMET MODULAR FEMORAL HEAD WHEN USED IN CONJUNCTION WITH A DEPUY FEMORAL STEM, HAVING AN APPROPRIATELY SIZED FEMORAL TAPER AND WHEN USED IN CONJUNCTION WITH AN APPROPRIATE ACETABULAR COMPONENT IS INTENDED FOR USE IN PRIMARY OR REVISION OF HIP JOINT MOBILITY AND REDUCTION IN JOINT PAIN.
INTENDED PURPOSETHE FEMORAL HEAD IS INDICATED FOR USE IN TOTAL OR PARTIAL HIP REPLACEMENT PROCEDURES FOR PATIENTS SUFFERING SEVERE PAIN AND DISABILITY DUE TO STRUCTURAL DAMAGE IN THE HIP JOINT FROM RHEUMATOID ARTHRITIS, OSTEOARTHRITIS, POST TRAUMATIC ARTHRITIS, COLLAGEN DISORDERS, AVASCULAR NECROSIS AND NONUNION OF FEMORAL FRACTURES. USE OF THE PROSTHESIS IS ALSO INDICATED FOR PATIENTS WITH CONGENITAL HIP DYSPLASIA, PROTRUSIO ACETABULI, SLIPPED CAPITAL FEMORAL EPIPHYSIS AND DISABILITY DUE TO PREVIOUS FUSION, WHERE BONE STOCK IS INADEQUATE FOR OTHER RECONSTRUCTIVE TECHNIQUES.
VALIDITY DATE OF REGISTRATION04-12-2017 - 03-12-2022

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1ULTAMET™ METAL ON METAL FEMORAL HEAD ? 28mm -3, 9/10 TAPER962700100
2ULTAMET™ METAL ON METAL FEMORAL HEAD ? 28mm +0, 9/10 TAPER962701100
3ULTAMET™ METAL ON METAL FEMORAL HEAD ? 28mm +3, 9/10 TAPER962702100
4ULTAMET™ METAL ON METAL FEMORAL HEAD ? 28mm +6, 9/10 TAPER962703100
5ULTAMET™ METAL ON METAL FEMORAL HEAD ? 36mm -3, 9/10 TAPER962710000
6ULTAMET™ METAL ON METAL FEMORAL HEAD ? 36mm +0, 9/10 TAPER962711000
7ULTAMET™ METAL ON METAL FEMORAL HEAD ? 36mm +3, 9/10 TAPER962712000
8ULTAMET™ METAL ON METAL FEMORAL HEAD ? 36mm +6, 9/10 TAPER962713000