Metal liner components of R3 acetabular system (used in hip replacements)
Product recall & cancellation
13 June 2012
The Therapeutic Goods Administration (TGA) advises that the R3 metal liner component of the R3 acetabular system (used in hip replacements) is being recalled by the Australian sponsor, Smith & Nephew Surgical Pty Ltd.
This recall is due to a higher than expected rate of revision surgeries for this particular component. This action is being taken globally.
Data sourced from Australia's National Joint Replacement Registry (NJRR) and United Kingdom's National Joint Registry have identified that the R3 acetabular system with metal liners has a higher rate of revision surgery than the average for total conventional hip replacements.
The TGA is in the process of cancelling the R3 metal liners from the Australian Register of Therapeutic Goods.
It is important to note that the rate of revision surgery of R3 acetabular components used in conjunction with ceramic or polyethylene liners (sometimes called inserts) is in line with the expected rate of revision surgeries and are not affected by this recall and product cancellation.
The Smith & Nephew R3 acetabular system was designed to accommodate several different bearing surfaces such as plastic on metal, ceramic on ceramic and metal on metal (MoM) and can be used with different combinations of femoral stem components to form a total hip replacement.
The affected R3 acetabular system consists of two components:
- the R3 acetabular cup
- R3 metal liners made of cobalt-chromium (CoCr) that fit within the acetabular cup.
When an R3 metal liner is used in combination with a metal femoral head, then the resulting implant combination is a MoM hip replacement system. The TGA is closely monitoring all MoM hip replacement systems.
If you have an R3 acetabular system as a component in your hip replacement please contact your implanting surgeon to check whether R3 metal liners were used. If you have an R3 metal liner and a metal femoral head please arrange a review appointment.
Each patient's circumstances are different, and the TGA is not able to give individual clinical advice regarding the R3 acetabular system.
The information in this statement includes the latest scientific information available to the TGA; hopefully it will assist medical practitioners and patients to jointly make informed decisions about their continuing medical treatment.
More information on this global recall is available from the Smith & Nephew website.
Smith & Nephew Surgical Pty Ltd, has written to all Australian orthopaedic surgeons who have implanted the R3 acetabular system with metal liners and advised them to:
- implement appropriate follow-up protocols for their patients such as the Medicines and Healthcare Products Regulatory Agency (MHRA) advice about the management and monitoring of patients implanted with MoM hip replacements
- contact their patients who have been implanted with the R3 metal liner as part of the hip replacement surgery and advise them of the issues.
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.
The most recent data sources related to the performance of the metal liner in the R3 acetabular system with metal liners include:
- The United Kingdom's National Joint Registry, which shows a revision rate of 6.3% at 4 years (compared to 2.89% at 4 years for all primary total hip replacements in the UK).
- The Australian Orthopaedic Association's NJRR which shows a revision rate of 2.48 revisions per 100 observation years (compared with a revision rate of 0.79 revisions per 100 observation years for all primary total hip replacements in Australia).
Smith & Nephew is advising that the registry data do not indicate if there is a single, dominant reason why the R3 metal liner is not performing to the required standard (such as issues relating to metallurgical or other manufacturing processes).
According to information available to the TGA from the NJRR, 602 R3 acetabular systems with metal liners have been implanted in Australian patients, and 47 have been revised.
A review of the NJRR data revealed that the revision rate for the R3 acetabular system using polyethylene and ceramic liners is in line with that of all other conventional total hip replacements.
Consumers and health professionals are encouraged to report problems with medical devices. Please refer to the TGA Internet site for more information on the TGA Incident Reporting and Investigation Scheme (IRIS).
You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.
Content last updated: Wednesday, 13 June 2012
Web page last updated: Tuesday, 22 October 2013