Apex K2 Femoral Stem (used in hip replacements)
Cancelled due to high revision rate
The Apex K2 Femoral Stem, sponsored by Global Orthopaedic Technology, is a component used in hip replacements. The stem has not been used extensively in metal-on-metal (MoM) hip replacements.
The TGA advises health professionals and patients that Global Orthopaedic Technology has cancelled the Apex K2 Femoral Stem from the Australian Register of Therapeutic Goods (ARTG).
The decision to cancel was based on an analysis of data collected by the Australian National Joint Replacement Registry (NJRR), which revealed that the Apex K2 Femoral Stem had a higher than expected revision rate.
The TGA's routine processes involve close analysis of NJRR annual reports, together with review of internal incident reports and consideration of external specialist advice.
If you have a hip replacement and have pain in your hip or thigh, you should consult your general practitioner (GP) and/or your orthopaedic surgeon.
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.
Each patient's circumstances are different and the TGA cannot give individual clinical advice regarding the Apex K2 Modular Hip Replacement System.
Given the nature of the problem, there is no urgent need to contact patients who have received an Apex K2 Modular Hip Replacement System. However, it is recommended that implanting surgeons conduct annual clinical and radiological examinations on those patients, in accordance with routine patient post-arthroplasty care, and advise them of this issue at that stage.
Global Orthopaedic Technology has issued a hazard alert about this issue to implanting surgeons who have previously used the Apex K2 Modular Hip Replacement System.
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 TGA monitors the safety and performance of orthopaedic implants using data collected by the NJRR since 2006. This and other recent hazard alerts relating to hip replacement implants have arisen from the TGA’s routine processes involving close analysis of the NJRR annual reports, together with review of internal incident reports and consideration of external specialist advice.
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.
The 2012 NJRR report indicated that the cumulative revision rate for the Apex K2 Modular Hip Replacement System was 5.5% at 1 year from the time of implantation and 9.3% at 3 years. A headline revision rate of 4.6 revisions per 100 observed years compared to 1.6% at 1 year and 2.8% at 3 years from implantation and a headline revision rate of 0.81 revisions per 100 observed years for all other total conventional hip replacements.
It is important to note that the Apex K2 Femoral Stem, which has not been supplied since early October 2011, has not been used extensively with MoM articulation - 55 out of the 598 Apex K2 Stems used in Australia were used with a MoM articulation and 5 of those were revised.
Patients 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 personal 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.