Consumers and health professionals are advised that Orthotech, in consultation with the TGA, has issued a hazard alert for its VAIOS Total Shoulder Replacement System due to higher-than-expected revision rates.
Orthotech ceased supply of this device on 14 August 2015 after its cancellation from the Australian Register of Therapeutic Goods.
VAIOS Total Shoulder Replacement System comprises various components used in total shoulder replacement surgeries. It first became available in Australia in June 2010.
Information published by the Australian Orthopaedic Association's National Joint Replacement Registry (AOANJRR) indicated that, to December 2013, the VAIOS Total Shoulder Replacement System had a revision rate at two years of 17.6%.
The comparable revision rate at two years for all other total conventional shoulder implants was 5.5%.
This data indicated that, at December 2013, the VAIOS Total Shoulder Replacement System was four times more likely to need revision than other conventional shoulder implants.
The TGA analysed additional data from the AOANJRR collected to December 2014 and found that the revision rate of the implant was not improving.
Preventative removal of implanted VAIOS Total Shoulder Replacement System devices is not recommended at this time, as the risks of additional surgery outweigh the benefits if no problems are being experienced by the patient.
The hazard alert provides information to surgeons who implanted these devices about the above issues and advice about the ongoing management of affected patients.
Information for consumers
If you or someone you care for has had a shoulder replacement and you are concerned about this issue, speak to your health professional.
If you experience symptoms such as pain or instability, you should contact the orthopaedic surgeon who performed the implantation or the hospital where the operation was performed.
Information for health professionals
If you are treating a patient who has had a shoulder replacement, be aware of this issue.
Reassure them that, even if they have been implanted with the VAIOS Total Shoulder Replacement System, this issue may not affect them and there is no reason to remove an implanted device if they are not experiencing problems.
Patients with any shoulder replacement should be followed up by the implanting orthopaedic surgeon, particularly if they complain of pain and other symptoms associated with their implanted device.
Information for orthopaedic surgeons and hospitals
If you have implanted the VAIOS Total Shoulder Replacement System, it is recommended that you consider contacting those patients to inform them of this issue.
You are advised to maintain the routine follow-up protocol for patients who have undergone shoulder arthroplasty.
The need for any additional follow-up or revision surgery should be determined on a case-by-case basis following a detailed assessment of the patient’s clinical circumstances.
According to the AOANJRR data, the main reasons for revision were instability/dislocation, rotator cuff insufficiency and loosening/lysis.
If you have further questions or concerns regarding this issue, contact Orthotech on 07 3262 5033.
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.