Biolox Forte 36 mm Alumina ceramic heads - used in hip replacements

Hazard alert - increased risk of requiring revision

22 February 2017

Consumers and health professionals are advised that Surgical Specialties, in consultation with the TGA, is issuing a hazard alert for Biolox Forte 36 mm Alumina ceramic heads.

Biolox Forte 36 mm Alumina ceramic heads

Biolox Forte 36 mm Alumina ceramic heads are a component used in total hip replacements. The ceramic head is the part of a hip replacement that replaces the 'ball' part of the joint.

Biolox Forte 36 mm Alumina ceramic heads are sponsored by Surgical Specialties and manufactured by MicroPort Orthopedics.

Please note that Biolox Forte 36 mm Alumina ceramic heads have not been used in Australia since 2014 and have been withdrawn from the Australian Register of Therapeutic Goods.

An investigation following a complaint by a surgeon has found that Biolox Forte 36 mm Alumina ceramic heads are 2 mm shorter than other 36 mm MicroPort femoral heads. The affected products are:

  • Ceramic Femoral Head 36 mm SLT Taper Short Neck (part number 26000010)
  • Ceramic Femoral Head 36 mm SLT Taper Medium Neck (part number 26000011)
  • Ceramic Femoral Head 36 mm SLT Taper Long Neck (part number 26000012)

These products had been manufactured to this specification for more than 15 years.

This issue means patients who have received a hip replacement using these Biolox Forte 36 mm Alumina ceramic heads may be at increased risk of requiring revision surgery due to dislocation or laxity (looseness) of the hip joint.

MicroPort Orthopedics, reports that after being distributed for more than 15 years, the rate of dislocations involving these components is approximately 0.225%.

No other MicroPort Orthopedics-manufactured products are affected by this hazard alert.

Information for consumers

If you or someone you provide care for has received a Biolox Forte 36 mm Alumina ceramic head as part of a total hip replacement, be aware of this issue.

If you have any questions or concerns about this issue, talk to your health professional.

Contact the implanting orthopaedic surgeon if you experience pain, instability, difficulty walking and/or difficulty performing common tasks, related to your implant.

Information for all health professionals

If you are treating someone who has received a Biolox Forte 36 mm Alumina ceramic head as part of a total hip replacement, advise them of this issue. However, reassure them that only a small number of patients who have received these implants have experienced problems associated with this issue.

Patients with an affected implant should be followed up by the implanting orthopaedic surgeon if possible, particularly if they complain of pain, instability, difficulty walking and/or difficulty performing common tasks, related to their implant.

Information for orthopaedic surgeons

The sponsor has written to orthopaedic surgeons who have implanted affected Biolox Forte 36 mm Alumina ceramic heads to provide further information about this issue.

If you are managing the treatment of a patient who has a Biolox Forte 36 mm Alumina ceramic head, you are advised to maintain routine follow-up protocol for those patients. Advise them of the potential signs and symptoms relating to this issue, particularly pain, instability, difficulty walking and/or difficulty performing common tasks.

If you have any questions or concerns about this issue, contact Surgical Specialties on 1300 665 884.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.