Essential Product Information for Patients

Total Hip Prosthesis - Hemi-Hip Prosthesis

Important Note

This Essential Product Information does not include all of the information needed for proper use and care of a prosthetic hip implant. Please consult your physician for additional information.

The longevity of a prosthetic hip (how long it will last) varies from patient to patient. It depends on many factors, such as a patient's physical condition and activity level, body weight and the surgical technique. A prosthetic joint is not as strong or durable as a natural, healthy joint, and there is no guarantee that a prosthetic joint will last the rest of a patient's life. All prosthetic hips may need to be revised (replaced) at some point.

Indications

Your physician may determine that a hip replacement is appropriate for you if you have severe pain or significant disability resulting from one or more of the following conditions:

  • Deterioration of the hip joint cartilage (osteoarthritis)
  • Inflammation in the lining of the hip joint (rheumatoid arthritis)
  • Arthritis resulting from physical injury to the hip joint (traumatic arthritis)
  • Inflammation of multiple joints (polyarthritis)
  • Certain types of breaks (fractures) in the hip bone, and fractures which have not healed properly (nonunions)
  • A loss of blood supply to the ball of the hip bone (femoral head) which may lead to fractures within the bone and possible collapse (avascular necrosis)
  • Collagen disorders
  • A previous joint fusion
  • A previous hip joint replacement which has failed
  • Other problems with the hip joint (congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis)

Contraindications

Your doctor may decide that a hip replacement surgery is not appropriate if:

  • You have an infection.
  • You have injured or non-functional hip muscles.
  • You have one of several conditions known as neuromuscular disease.
  • You are skeletally immature.
  • You have poor quality bone.
  • You have poor skin coverage around the hip joint.

Warnings and Precautions

Excessive physical activity, trauma, and obesity can result in loosening, wear, and/or fracture of your hip implant.

Failure to follow through with the required rehabilitation program or failure to govern your physical activities as directed by your physician may cause your hip implant to fail.

Activities that place a lot of stress on the joint implants, as may be the case with heavier and more active patients, may reduce the service life of the prosthesis. Implant loosening and wear on the plastic portions of the implant can lead to additional surgery to replace the worn components, or all of the components. Talk with your doctor about the following points, and how they might affect the longevity and success of your joint replacement:

  • Avoiding repetitive heavy lifting
  • Avoiding excessive stair climbing
  • Maintaining appropriate weight
  • Staying healthy
  • Avoiding "impact loading" sports such as jogging, downhill skiing and high impact aerobics
  • Consulting your surgeon before beginning any new sport or activity
  • Thinking before you move
  • Avoiding any physical activities involving quick stop-start motion, twisting or impact stresses
  • Avoiding excessive bending when weight bearing, like climbing steep stairs
  • Not lifting or pushing heavy objects
  • Not kneeling
  • Avoiding low seating surfaces and chairs

Adverse Effects

The following events are possible complications of hip replacement surgery. Additional surgical procedures may be required to address these complications.

  • Loosening of the prosthetic hip components
  • Disassembly of the prosthetic hip components
  • Fracture of the prosthetic hip components
  • Malalignment and/or dislocation of the prosthetic hip components resulting from surgical malpositioning, muscle and fibrous tissue laxity (looseness), and/or bony impingement
  • Bone fracture or injury resulting from the hip replacement surgery, rehabilitation, or from trauma
  • Abnormal bone overgrowth (heterotopic bone formation) which may lead to fixation, stiffness, or immobility of the joint
  • Nerve or vascular (blood vessel) damage
  • Infection
  • Pain

Complications and/or failure of total hip replacements are more likely to occur in:

  • Patients with unrealistic functional expectations.
  • Heavy patients, especially those over 225 lbs (102 kg).
  • Small-boned patients.
  • Physically active patients.

The following complications are also possible:

  • You may have adverse reactions to the materials contained in the prosthetic hip. These reactions may range from an allergic reaction to cancer and/or tumors. Discuss these possible complications with your physician, especially if you have a history of allergies, metal sensitivity, or Paget's disease.
  • Debris generated from unavoidable wear of the prosthetic components may cause osteolysis (bone disintegration) and loosening of the implant, resulting in the need for additional surgery.
  • Corrosion of the prosthetic components may occur, and may result in the need for additional surgical intervention.