Post-market review of metal-backed patellae

We received signals relating to MBP implants, their adverse events, and higher than expected rate of early revision surgery. 

While metal-backed patellar components were used to provide added strength and potentially better fixation to underlying bone, some have shown elevated rates of early failure when compared to all-polyethylene patellae. These failures often meant patients had to undergo revision surgery much sooner than expected, sometimes within just a few years, to replace the worn or fractured component, which compromised implant longevity and patient outcomes.

In response to these signals, we initiated a post-market review of all MBP implants/knee replacements included in the Australian Register of Therapeutic Goods (ARTG).

As part of ARTG inclusion sponsors and manufacturers have a range of post-market obligations. This includes maintaining evidence that devices continue to be safe and perform as intended throughout their lifecycle and providing this evidence to us when requested.

The purpose of the review was to assess the safety and performance of devices for their intended purpose. Patellar components that are solely made of polyethylene or other non-metallic materials and knee replacements that do not contain patellar components are out of scope of the review. 

As part of the review, we required all sponsors of MBP devices included in the ARTG to provide information for their devices. This included:

• Supply information
• Advertising materials
• Labelling information, including Instructions for Use (IFU)
• Patient implant card (PIC) and patient information leaflets (PILs)
• Complaint and adverse event reports
• Risk-benefit analysis of device
• Clinical evidence supporting the safety and performance of the device
• Revision analysis of the device’s AOANJRR data.

During the review, we also considered a range of information to ensure all regulatory decisions are evidence-based, including analysis of registry data from the Australian Orthopaedic Association National Joint Replacement Register (AOANJRR) and data held by sponsors and manufacturers for their device.

The post-market review of MBP devices is now complete. The review confirmed that some patients still benefit from these devices in specific clinical circumstances.  We continue to closely monitor MBP devices to support ongoing safety.

The outcomes of the review include:

• No regulatory action taken.
• Voluntary cancellation by the sponsor.
• Conditions of Inclusion.

A condition enables us to closely monitor the devices over time and take action promptly if any issues are identified. Where conditions have been imposed, details can be found by searching the ARTG public summary with the ARTG number.

Some devices remain available with additional regulatory oversight in place, while others have been withdrawn by sponsors. Although concerns were identified regarding higher rates of early revision for some MBP devices, they may continue to be appropriate for selected patients. As a result, some MBP devices remain included in the ARTG.

This webpage will be updated if any new issues are identified through the monitoring of the conditions.

An ARTG entry may be cancelled in two ways: 
(1) The sponsor (the supplier within Australia) may voluntarily cancel the entry or 
(2) the TGA may cancel the entry. The sponsor can cancel their entry at any time and is not required to provide a reason to the TGA.

Health professionals should ensure they provide sufficient information about these devices to enable informed and educated consent from their patients. Appropriate patient selection for use of an MBP and device suitability for individual conditions remain of utmost importance when considering the use of these devices.

For health professionals/hospitals who want to use a device that has been cancelled from the ARTG:

• You can import or supply cancelled devices or accessories by applying under the Special Access Scheme (SAS) or Authorised Prescriber (AP) scheme if you feel your patient requires a device that is no longer included on the ARTG. To supply an unapproved device under the SAS or AP scheme there must be no suitable devices in the ARTG for the relevant condition(s) and patient(s).

Health professionals should continue to report all adverse events associated with an MBP implant to the TGA when they occur. 

Health professionals should further ensure their patients are aware of how to report device concerns to the sponsor and the TGA.

Although some devices have been cancelled from the ARTG, they are not being recalled from the market and do not need to be removed if already implanted.

Consumers should consult their treating health professional if they have any questions regarding the safety or performance of their MBP device. 

We 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.

When an MBP is discussed as an option for care, ensure that you receive information on all your care options, including any education on both the risks and benefits of this treatment for you as an individual. You may wish to access the TGA’s Five questions to ask your health professional before you get a medical implant.

Patient safety is a priority for the TGA. Patients should be encouraged to report all adverse events to the TGA regarding medical devices, including software and artificial intelligence.

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).