DEVICE DETAILS
| NAME OF DEVICE | ULTAMET FEMORAL HEAD |
|---|---|
| ESTABLISHMENT NAME | JOHNSON & JOHNSON SDN BHD |
| REGISTRATION NO | GC18716509217 |
| BRAND NAME | ULTAMET |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | DEPUY 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. |
| DEVICE INTENDED PURPOSE | THE 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 REGISTRATION | 04/12/2017 - 03/12/2022 |