Metallic femoral head - Vietnam Registration 2400393ĐKLH/BYT-HTTB

The product is a component of the total and partial hip arthroplasty systems and the partial hip arthroplasty systems, and is intended to be used in surgery without cement in total and partial hip arthroplasty and partial hip arthroplasty. INTENDED USE Total hip arthroplasty surgery is intended to improve the mobility of the patient and reduce pain by replacing the damaged surface of the hip joint in patients who have been proven to have sufficient healthy bone to anchor and support the artificial joint components. INDICATIONS Total hip arthroplasty surgery is indicated in the following conditions: 1. Severe pain and/or hip joint disability due to chronic arthritis, arthritis after trauma, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute fracture of the femoral head or neck due to trauma. 4. Failed previous hip surgery, including arthroplasty revision, intramedullary fixation, arthrodesis, partial joint arthroplasty, surface replacement arthroplasty, or total hip arthroplasty. 5. Some cases of joint stiffness. INTENDED USE Partial hip arthroplasty systems are intended to be used in partial hip arthroplasty surgery when there is evidence of a suitable natural acetabulum and sufficient femoral bone to anchor and support the femoral stem. INDICATIONS Partial hip arthroplasty surgery is indicated in the following conditions: 1. Acute fracture of the femoral head that cannot be treated effectively with intramedullary fixation. 2. Dislocation of the hip joint that cannot be treated effectively with intramedullary fixation. 3. Avascular necrosis of the femoral head. 4. Nonunions of the femoral neck. 5. Some cases of high femoral neck fractures in the elderly. 6. Osteoarthritis of the hip joint that affects only the femoral head and does not require replacement of the acetabulum. 7. Conditions that affect only the femoral head/neck and/or the greater trochanter of the femur and can be effectively treated by partial hip arthroplasty surgery. Total or partial hip arthroplasty surgery may be considered in younger patients, if, in the opinion of the surgeon, the clear indication for total hip arthroplasty surgery outweighs the risks associated with the patient's age and if the requirements for range of motion and load-bearing capacity of the hip joint can be met (see section WARNINGS AND PRECAUTIONS). This section includes severely disabled patients with multiple joint involvement, for whom increased hip joint mobility may result in a significant improvement in quality of life.