The 2014 annual report of the Australian Orthopaedic Association’s National Joint Replacement Registry (AOANJRR) is now available on the AOANJRR website.
The annual report contains information about hip, knee and shoulder orthopaedic implants that are having higher-than-expected rates of revision.
The TGA assesses the data published in each year’s report and works closely with the AOANJRR to investigate implants that have been identified by the registry.
Monitoring revision rates
All orthopaedic implants have a limited life in the human body and may need to be revised at some point. However, it is important to monitor implants to ensure that they do not require replacement too often or too soon after implantation, and that any adverse events are minor compared to the health benefits of having the implant.
Higher rates of revision are of concern because orthopaedic surgery can have significant health risks. However, joint replacement surgery is considered to be one of the most effective forms of surgical intervention and rates of revision are generally low, even for many of the implants identified by the AOANJRR. Also, there are many reasons why a particular implant may be having a higher than expected rate of revision, therefore not all such implants require regulatory intervention.
The TGA has now commenced its review of the AOANJRR data. In reviewing whether the implants identified in the 2014 annual report of the AOANJRR require regulatory intervention, the TGA will seek advice from the Orthopaedic Subcommittee (OSC) of the Advisory Committee on the Safety of Medical Devices. The OSC advises the TGA whether the revision rates reported in the report of the AOANJRR are of significant clinical concern. Based on this advice and other information, including that provided by the relevant sponsor, the TGA then decides whether regulatory intervention is needed.
The review process is complex and lengthy, but when regulatory intervention is necessary it is reported to all surgeons who have used the implants through a hazard alert and details of the action/intervention are published on the TGA website.
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.