Therapeutics Goods Administration (TGA) published an assessment of Australia’s national joint replacement registry report.

TGA Joint Registry Report

Annually the Therapeutics Goods Administration (TGA) publishes its assessment of the Australian Orthopaedic Association’s National Joint Replacement Registry (AOANJRR) report. This data is crucial to orthopedic companies as a recent source of post-market surveillance for their products and competitors and the development of Post-Market Clinical Follow-up (PMCF) study protocols.

You can download the most recent annual report, and the thirteen supplemental reports, from the following website: (http://bit.ly/AOA2013Reports). As you can see from the list below, this release is more extensive than previous annual reports that did not include the supplementary reports. This should be especially important for spinal companies that will be reclassifying (http://bit.ly/gapanalysiscmda) their CE Marked products from Class IIb to Class III and submitting a Design Dossier in 2014/2015.

2013 Annual Report

• Hip & Knee Arthroplasty (September 1999 to December 2012) – 213 pages

2013 Supplementary Reports

1. Analysis of State and Territory Health Data All Arthroplasty – 19 pages
2. Cement in Hip & Knee Arthroplasty – 15 pages
3. Demographics and Outcomes of Elbow & Wrist Arthroplasty – 32 pages
4. Demographics and Outcome of Ankle Arthroplasty – 11 pages
5. Demographics and Outcomes of Shoulder Arthroplasty – 65 pages
6. Demographics of Hip Arthroplasty – 28 pages
7. Demographics of Knee Arthroplasty – 23 pages
8. Demographics of Spinal Disc Arthroplasty – 11 pages
9. Lay Summary 2013 Annual Report Hip and Knee Replacement – 13 pages
10. Metal on Metal Total Conventional Hip Arthroplasty – 13 pages
11. Mortality following Primary Hip and Knee Replacement – 10 pages
12. Revision of Hip & Knee Arthroplasty – 21 pages
13. Unispacer Knee Arthroplasty – 6 pages

Post-Market Clinical Data

The requirement to conduct PMCF studies is not new. The release of MEDDEV 2.12/2 rev 2 in 2012 increased the orthopedic industry’s awareness of this tool’s purpose and importance. In Europe, Notified Bodies are required to verify that manufacturers have included a PMCF protocol as part of the Post-Market Surveillance (PMS) plan. The requirement for PMCF studies is found in Annex XIV of EU MDR. It states that “PMCF shall be understood to be a continuous process that updates the clinical evaluation.” 

Most orthopedics manufacturers attempt to provide a justification for not conducting PMCF studies, yet implant recalls, and the prevalence of revision surgery have increased the scrutiny around these justifications. Hamish Forster, a former Notified Body specialist at TUV SUD, wrote a white paper on “The Post-Market Imperative: Understanding the requirements for effective post-market clinical follow-up.”