Essential Product Information for Patients

Total Elbow Prosthesis

Important Note

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

The longevity (length of life) of a prosthetic elbow 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 elbow will last the rest of a patient's life. All elbow prostheses may need to be replaced at some point.

Indications

Your physician may determine that an elbow replacement is appropriate if you have one or more of the following conditions:

  • Bone injury or bone loss contributing to elbow instability
  • Abnormal stiffness, immobility, and consolidation of the elbow joint (ankylosis)
  • Painful deterioration of the elbow joint cartilage (osteoarthritis)
  • Painful inflammation in the lining of the elbow joint (rheumatoid arthritis)
  • Arthritis resulting from physical injury to the elbow joint (traumatic arthritis)
  • Elbow joint instability or loss of motion, which cannot be satisfactorily addressed by more conservative treatment options
  • A previous elbow joint replacement, which has worn or failed

Contraindications

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

  • You have an infection
  • You have a nerve disorder causing loss of movement or sensation to the elbow area (joint neuropathy)
  • You have paralysis or significant hand dysfunction
  • You have excessive scarring of the skin around the elbow joint
  • Your activities would subject the implant to significant stress (e.g. heavy labor, torsional stress, or competitive sports)

Warnings and Precautions

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

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

Activities that place a lot of stress on the joint implants, as may be the case with 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 lifting, lifting anything heavier than one pound during recovery, and lifting anything heavier than five pounds after recovery
  • Avoiding "jamming" activities such as hammering
  • Staying healthy
  • Avoiding "impact loading" sports such as boxing
  • Consulting your surgeon before beginning any new sport or activity, to find out what type and intensity of sport or activity is appropriate for you
  • Thinking before you move
  • Avoiding any physical activities involving quick stop-start motion, twisting or impact stresses on the operated elbow
  • Not pushing heavy objects

Adverse Effects

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

  • Loosening of the prosthetic elbow components
  • Disassembly of the prosthetic elbow components
  • Fracture of the prosthetic elbow components
  • Bone fracture or injury resulting from elbow replacement surgery, rehabilitation or trauma
  • Nerve and/or muscle injury (triceps avulsion)
  • Infection
  • Pain
The following complications are also possible:
  • Adverse reactions to the materials in the prosthetic elbow. 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 implant caused by unavoidable wear of the prosthetic components. Additional surgery may be needed.
  • Corrosion of the prosthetic elbow components, which may result in the need for additional surgical intervention.