Consumers and health professionals are advised that Microport Orthopedics, in consultation with the TGA, has issued a hazard alert for components used in metal-on-metal (MoM) hip implants due to an increasing rate of revisions and suspected tissue reactions to metal debris.
Microport Orthopedics issued the hazard alert due to the increasing revision rate identified overseas since 2009. It said there had been few users in Australia and the rate of revision in this country had been low.
In MoM hip implants the two moving surfaces in the joint are both made of metal. There is a growing body of evidence that because the two moving parts of a MoM hip implant wear against each other they can release trace amounts of cobalt and chromium (Co/Cr) into the patient's body.
Microport Orthopedics metal-on-metal total hip replacement components have not been used in Australia since 2013 and have been cancelled from the Australian Register of Therapeutic Goods.
The components affected by this hazard alert are:
- Conserve resurfacing cup
- Dynasty metal liner
- Rim Lock metal liner
- Lineage metal liner.
Information for consumers
Microport Orthopedics has written to health professionals who have implanted affected components, providing them with information and recommendations on patient follow-up.
If you, or somebody you provide care for, has had a metal-on-metal hip implant you are encouraged to review the TGA statement: Metal-on-metal hip implants: Information for patients.
If you are not sure what type of hip replacement you have or if you have concerns about your hip replacement, you should seek information from the surgeon who performed the operation or the hospital where the operation was performed.
If you have a hip replacement and have pain in your hip or thigh, or any other issues you think may be related to the implant such as instability or difficulty walking, you should consult your general practitioner (GP) and/or your orthopaedic surgeon. Your GP/surgeon will usually order X-rays and may in some instances order further tests such as ultrasound, MRI and blood tests.
Information for health professionals
Patients with any hip replacement should be followed up by the implanting orthopaedic surgeon if possible, particularly if the patient complains of pain and other symptoms associated with their hip implant and surgery.
Information for orthopaedic surgeons
Microport Orthopedics has written to surgeons advising them of this issue.
Microport Orthopedics advises that being alert to rising levels of cobalt and chromium in serial blood tests, in conjunction with X-ray, MRI and ultrasound can be valuable in the follow-up of patients.
Recipients of total conventional MoM implants with a large femoral head, and recipients of total resurfacing implants who are female and/or have a small femoral head are at a higher risk of metal pathology related complications leading to revision. These patients should receive particularly close follow-up.
Surgeons are also advised to review the TGA's guidelines for MoM hip replacement implants.
If you have any questions or concerns relating to this issue, contact Mircroport Orthopedics' Australian representatives, Surgical Specialties, by phone on 1300 665 884.
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.