| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00976-1 |
| Product Name/Description |
Vaios Total Shoulder Replacement System
ARTG Number: 173236 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/10/2015 |
| Responsible Entity |
|
| Reason/Issue |
The TGA has cancelled the VAIOS Total Shoulder Replacement System, sponsored by Orthotech, from the Australian Register of Therapeutic Goods (ARTG) due to a higher than expected revision rate. Information published by the Australian Orthopaedic Association’s National Joint Replacement Registry (AOANJRR) indicated that the VAIOS Total Shoulder Replacement System had a revision rate at two years of 17.6%. The comparable revision rate for all other total conventional shoulder implants was 5.5% at two years. The main reasons for revision were instability/dislocation, rotator cuff insufficiency and loosening/lysis. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Orthotech are advising clinicians to consider contacting patients who have been implanted with these devices to inform them of this issue. Implanting surgeons are advised to maintain their 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. This action has been closed-out on 29/08/2016. |
| Contact Information |
07 3262 5033 - Orthotech Pty Ltd |