Durom Acetabular Component (used in hip replacements)
Cancelled due to high revision rate
The Durom Acetabular Component, manufactured by Zimmer, is an implant used in metal-on-metal (MoM) hip replacements. It can be used for both MoM resurfacing and total conventional hip replacement procedures.
The TGA advises health professionals and patients that Zimmer has cancelled the implant from the Australian Register of Therapeutic Goods (ARTG).
The decision to cancel the Durom Acetabular Component from the ARTG was based on an analysis of data collected by the Australian National Joint Replacement Registry (NJRR), which revealed that the implant had a higher than expected revision rate.
Use of the Durom Acetabular Component had declined since 2005, with the last use of the implant recorded in June 2011.
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.
The TGA closely monitors all MoM hip replacement systems.
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 Durom Acetabular Component.
The TGA recommends that surgeons contact their patients who have these implants and inform them of this alert.
Zimmer has issued a hazard alert about this issue to implanting surgeons who have previously used this component.
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 2011 NJRR report revealed that the Durom Acetabular Component's cumulative revision rate was 9.6% at 7 years in resurfacing applications (compared to 6.1% for all other similar implants) and 6.8% at 5 years in total conventional hip replacements (compared to 3.6% for all other similar implants).
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.