Australian Orthopaedic Association National Joint
Replacement Registry (NJRR): The Regulator’s Perspective
What is the NJRR?
An initiative of the Australian Orthopaedic Association (AOA), the Australian Orthopaedic Association National Joint
Replacement Registry (NJRR) is a registry designed to improve and maintain the quality of care for Australians
receiving joint replacement surgery – specifically hip, knee, shoulder, elbow, wrist, ankle, or spinal disc replacements.1
Viewed as a leader due to its high standards for data collection, validation, and security, the NJRR has proved useful
to a broad range of stakeholders in Australia and abroad, including the Australian Therapeutic Good Administration
(TGA).2
What is TGA?
The TGA is part of the Australian Government Department of
Health. Similar to the U.S. Food and Drug Administration, the
TGA’s overall purpose is to protect public health and safety by
regulating therapeutic goods that are imported and manufactured,
or exported from Australia. Regulated therapeutic goods include
medicines, medical devices, human blood, blood products, and
tissues.3
How does the TGA use the NJRR?
The TGA uses the NJRR to conduct research and monitor safety.
TGA officials conduct thorough reviews of devices identified as
outliers in NJRR’s annual report, which informs policy decisions
such as whether to retain or remove devices from the market. If
more information is needed, TGA officials can request additional
analyses and reports from the NJRR.
Who within the TGA uses the data?
Established in 2006, a group of nine orthopaedic surgeons and a
general surgeon called the Orthopaedics Subcommittee (OSC) is
tasked with reviewing NJRR data to identify device implants of
concern. The OSC then advises the TGA to either continue observation or investigate further, implying a potential policy action.4
Why does the TGA use the NJRR?
Many TGA officials note that the NJRR is a highly credible
source of information, in part because analyses are independently conducted and interpreted by those outside the Australian
government. The Registry is viewed as reliable and appropriately
“at arm’s distance” from regulators using this information; and
therefore, free of biases and external party influences.5
Example Spotlight: Journey Bi-Cruciate Stabilized Knee Replacement
In January 2014, the TGA (in collaboration with device manufacturer Smith & Nephew) issued a hazard alert regarding the femoral
implant component of the Journey Bi-Cruciate Stabilised (BCS) knee replacement. The Journey BCS knee system is a total knee
replacement system, meaning that it is used during a patient’s first knee replacement surgery. The NJRR identified this device as
having a higher than expected revision rate when compared to all other total knee replacements.
Based on this information, Smith & Nephew has withdrawn this component of the replacement system from the Australian market.
The TGA conducted a thorough review process before putting forth this recommendation to the manufacturer. The process included
close analyses of NJRR annual reports and a thorough review of internal incident reports, as well as some external expert opinion.6
This recent example illustrates the NJRR’s utility for the TGA – the NJRR assists in the Administration’s goal to protect public health
and secondly, saves the health care system money by avoiding revision rate surgeries.
Australian Orthopaedic Association National Joint Replacement Registry (NJRR): The Regulator’s Perspective
Potential Future Uses
In addition to annual reports identifying implants with high
revision rates, regulators have requested further detailed analyses,
including expert opinion analyses. These analyses would likely
involve solicitation of input from multiple experts (likely surgeons
or other therapeutic good users) with direct experience using
the product identified in a given report. Such expert opinion
would provide regulators with additional context and insight into
real-world application of the medical device in question, and thus
provide another source of data to inform the decision-making
process. This level of information is not currently provided in
Registry analyses and associated publications.
Australian Government Department of Health Therapeutic
Goods Administration, Journey Bi-Cruciate Stabilised (BCS)
Knee Replacement System – Femoral Implant, available at: http://
www.tga.gov.au/safety/alerts-device-journey-bcs-knee-replacement-system-140106.htm#.U1gJ801OVD8. Accessed May 29,
2014.
6
About the Authors
Jessica Winkler, M.P.H., is a senior associate at AcademyHealth.
She can be reached at Jessica.winkler@academyhealth.org.
Emily Moore is a research assistant at AcademyHealth.
Citations
1
Australian Orthopaedic Association National Joint Replacement
Registry, Home, available at: https://aoanjrr.dmac.adelaide.edu.
au/en/home. Accessed May 29, 2014.
2
Key informant interview, Spring 2014.
3
Australian Government Department of Health Therapeutic
Goods Administration, Who We Are & What We Do, available
at: https://www.tga.gov.au/about/tga-who-we-are.htm#.U1bMuk1OVD8. Accessed May 29, 2014.
4
Garcia, J. How the TGA uses The Australian Orthopaedics Associations National Joint Replacement Registry (AOANJRR) Data,
Working Paper.
5
Key informant interview, Spring 2014.
Acknowledgements
Sponsorship for this project was provided by The Pew Charitable
Trusts. We thank our partners at Kaiser Permanente Institute for
Health Policy and all those interviewed for their contributions to
these resources. A special thank you to Stephen Graves, M.D.,
Richard de Steiger, M.D., Adrian Cosenza, Ann Tomkins, and
other registry staff for their review and assistance.
This document represents a synthesis of information generated by a series of key informant interviews. Any views expressed are those of the interviewees.