CDSCO UID IMP/MD/2019/000172_a567c1a8f600f80a366dccf301dd436d_e932cddca359d0adc838846990247bf6

Hip Replacement System- Revision Stem

Johnson & Johnson Private Limited·Device Class Class D·India CDSCO·Brand: Marathon XLPE

Registration details

UID: IMP/MD/2019/000172_a567c1a8f600f80a366dccf301dd436d_e932cddca359d0adc838846990247bf6
Device class: Class D
Brand name: Marathon XLPE
License holder: Johnson & Johnson Private Limited
Approving authority: CDSCO
Product information: TOTAL HIP PROSTHESIS Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, herniarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. HEMI-HIP PROSTHESIS Hemi-Hip Prostheses are intended to be used for hemi-hip arthroplasty where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem. Hemi-hip arthroplasty is indicated in the following conditions: 1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. Avascular necrosis of the femoral head. 4. Non-union of femoral neck fractures. 5. Certain high subcapital and femoral neck fractures in the elderly. 6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty. 8. Where the acetabulum becomes symptomatic following hemi-hip arthroplasty, conversion to a total hip arthroplasty with retention of the modular hemi arthroplasty stem, with a new acetabular cup and compatible femoral head, may be preferable to revision of the hemi-hip prosthesis. Total or hemi hip arthroplasty may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for hip replacement outweighs the risks associated with the age of the patient and if limited demands regarding activity and hip joint loading can be assured (Marathon XLPE). This includes severely crippled patients with multiple joint involvement for whom a gain in hip mobility may lead to an expectation of significant improvement in the quality of their lives