Consumers and health professionals are advised that RQSolutions, in consultation with the TGA, has issued a hazard alert for its DeltaLox range of acetabular shells used in hip implants due to higher than expected revision rates. RQSolutions is also undertaking a recall of unimplanted stock.
An acetabular shell is the "cup" that is placed in the acetabulum (the "socket" part of the hip joint) during a hip replacement procedure.
An analysis published alongside the 2014 Annual Report of the Australian Orthopaedic Association's National Joint Replacement Registry (AOAJNRR) indicates that the revision rate for DeltaLox acetabular shells is higher than expected.
RQSolutions has ceased supply of DeltaLox acetabular shells and has cancelled them from the Australian Register of Therapeutic Goods (ARTG).
Information for consumers
RQSolutions has written to hospitals and orthopaedic surgeons who have implanted or are treating patients who have been implanted with the affected devices providing further information about this issue.
If you are not sure what type of hip replacement you have, or if you have concerns about your hip replacement, you should contact the surgeon who performed the implantation or the hospital where the operation was performed.
Information for all health professionals
RQSolutions has written to hospitals and orthopaedic surgeons who have implanted or are treating patients who have been implanted with the affected devices providing further information about this issue, including advice to assist with following up and treating those patients.
Patients with any hip replacement should be followed up by the implanting orthopaedic surgeon if possible, particularly if they complain of pain and other symptoms associated with their hip implant and/or surgery.
Information for orthopaedic surgeons and hospitals
An analysis published alongside the 2014 Annual Report of the AOAJNRR indicates that the yearly cumulative percent revision of implants using DeltaLox acetabular shells is 5.9% at 1 year and 9.0% at 2 years. In comparison, the cumulative percent revision for other total conventional hip replacements is 1.6% at 1 year and 2.1% at 2 years.
The TGA recommends that you consider contacting patients who have been implanted with these devices and inform them of this issue.
Implanting surgeons are advised to schedule annual clinical and radiological examinations for patients who have been implanted with this device, in accordance with routine patient post-arthroplasty care.
RQSolutions has contacted hospitals which have been supplied with DeltaLox acetabular shells advising them of this issue and arranging for return of unimplanted stock.
The RQSolutions catalogue numbers of affected acetabular shells are:
- 15800144
- 15800146
- 15800148
- 15800150
- 15800152
- 15800154
- 15800156
- 15800158
- 15800160
- 15800162
- 15800164
- 15800166
- 15800168
If you have any questions or concerns, or need to arrange return of affected stock, telephone RQSolutions on 02 9882 2030 or email azoury.g@rqsolutions.com.au.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. 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.