Essential Product Information for Patients

Total Shoulder Prosthesis - Hemi-Shoulder Prosthesis

Important Note

This essential product information does not include all of the information needed for proper use and care of a prosthetic shoulder implant. Please consult your physician for more information.

The longevity (length of life) of a prosthetic shoulder varies from patient to patient. It depends on many factors, such as a patient's physical condition and activity level, 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 shoulder will last the rest of a patient's life. All prosthetic shoulders may need replacement at some point.

Indications

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

  • Deterioration of the shoulder joint cartilage (osteoarthritis)
  • Inflammation in the lining of the shoulder joint (rheumatoid arthritis)
  • Physical injury to the shoulder joint resulting in arthritis (traumatic arthritis)
  • Certain breaks in the shoulder bones (fractures)
  • A loss of blood supply to the top of the upper arm bone (humeral head) which leads to tiny breaks within the bone and possible collapse (avascular necrosis)

Contraindications

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

  • You have an infection
  • You have injured certain nerves and/or nerve networks in the shoulder area
  • You have injured or non-functional shoulder muscles
  • You have one of several conditions known as neuromuscular disease

Warnings and Precautions

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

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

Activities that place a lot of stress on the joint implants may reduce the service life of the prosthesis. Implant loosening and wear on the plastic portions of the implant can lead to 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 shoulder replacement:

  • Avoiding repetitive heavy lifting
  • Avoiding "jamming" activities such as hammering
  • Staying healthy
  • Avoiding "impact loading" sports such as boxing or tennis
  • Consulting your surgeon before beginning any new sport or activity, to discuss what type and intensity of sport or activity is appropriate for you
  • Any restrictions on movement
  • Not lifting or pushing heavy objects

Adverse Effects

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

  • Loosening of the prosthetic shoulder components
  • Dislocation of the prosthetic shoulder
  • Malalignment of the prosthetic shoulder components
  • Disassembly of the prosthetic shoulder components
  • Bone fracture resulting from the shoulder replacement surgery or rehabilitation or from trauma
  • Pain
  • Infection

The following complications are also possible:

  • Adverse reactions to the materials in the prosthetic shoulder. 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.
  • Osteolysis (bone disintegration) and loosening of the prosthetic shoulder components caused by unavoidable wear of the prosthetic shoulder. Additional surgery may be needed.
  • Corrosion of the prosthetic shoulder components, which may result in the need for additional surgical intervention.