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Health professionals and patients are advised that a review of post-market surveillance data has identified that the Adept 12/14 Modular Head has a higher than expected revision rate.
The Adept 12/14 Modular Head is a component used in metal-on-metal (MoM) total conventional hip replacements.
In Australia, the Adept 12/14 Modular Head became commercially available in 2005, but has not been used since November 2011.
The TGA's routine processes involve close analysis of the Australian Orthopaedic Association's National Joint Replacement Registry (NJRR) annual reports, together with review of internal incident reports and consideration of external specialist advice.
The TGA closely monitors all MoM hip replacement systems.
Information for consumers
Patients with MoM hip replacements 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 MoM hip replacement and have pain in your hip or thigh, 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.
Each patient's circumstances are different and the TGA cannot give individual clinical advice regarding the Adept 12/14 Modular Head.
Information for orthopaedic surgeons
The TGA recommends that surgeons contact patients who have received the Adept 12/14 Modular Head and inform them of this alert.
Furthermore, surgeons are advised to review the TGA's guidelines for MoM hip replacement implants and the Arthroplasty Society of Australia guidelines.
Johnson & Johnson Medical Pty Ltd, as a sponsor of DePuy International devices in Australia, has written to implanting surgeons who have previously used the component, providing further information and advice.
Information for all 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.
Additional information
The TGA began monitoring the safety and performance of orthopaedic implants using data collected by the NJRR in 2006. The annual reports of the NJRR, and detailed information about implants that were identified as having higher than expected revision rates going back a number of years, are available on the NJRR website.
In every instance recorded on the NJRR, an Adept MoM total conventional hip replacement comprised an Adept 12/14 Modular Head and an Adept Acetabular component, along with one of a number of femoral stem implants.
At this time, no concerns have been raised regarding the Adept Acetabular component when used in hip resurfacing implants. This alert only applies to the Adept 12/14 Modular Head when used in total conventional hip replacements.
In October 2011, the annual report of the NJRR indicated that Adept MoM total conventional hip replacements had a higher than expected revision rate. At that time, there had been seven revisions from 109 procedures recorded in the NJRR. The TGA reviewed the 2011/12 data and found that there was insufficient information to draw a firm conclusion concerning a relationship to the device.
In September 2012, the NJRR reported a cumulative revision rate of 7.1% (95% CI 3.6% to 13.6%) at 3 years, with eight revisions from 121 Adept MoM total conventional hip replacements. Loosening/Lysis was identified as the reason for four of the eight revisions. The other four revisions were due to infections (two cases), prosthesis dislocation and pain (one case each).
UK National Joint Registry data published in November 2012 indicated a cumulative revision rate of 12.1% (95% CI 9.5% to 15.4%) at 7 years for the Adept 12/14 Modular Head when used in total conventional hip replacements.
The primary reasons for revisions identified in the UK National Joint Registry were aseptic loosening of the stem, soft tissue reaction and pain.
The data from both the NJRR and the UK National Joint Registry suggested that the revision rate of the Adept 12/14 Modular Head was high regardless of which femoral stem was used.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. 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.