| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01502-1 |
| Product Name/Description |
balanSys UNI convex polyethylene (PE) inlay x/5 (with thickness 5)
(Unicondylar knee prosthesis)
balanSys UNI convex PE inlay A/5
Item Number: 77.30.0211
balanSys UNI convex PE inlay B/5
Item Number: 77.30.0221
balanSys UNI convex PE inlay C/5
Item Number: 77.30.0231
balanSys UNI convex PE inlay D/5
Item Number: 77.30.0241
balanSys UNI convex PE inlay E/5
Item Number: 77.30.0251
All Batch Numbers
ARTG Number: 212828 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
Seven reports have been received concerning in situ inlay breakage of balanSys UNI convex PE inlays x/5 after approximately five years. The observed occurrence rate for inlay breakage amounts to 1.4% and this higher than anticipated rate has led to the decision by Mathys Orthopaedics Pty Ltd to remove all balanSys UNI convex PE inlays x/5 from the market as a precautionary measure. The breakage of a balanSys UNI convex PE inlay x/5 happens without prodromal symptoms. It presents itself with PE inlay dislocation that requires urgent revision to regain total functionality and to
prevent the surface of the metal components from any damage.
Please note that all other balanSys UNI convex PE inlay sizes are not affected by this action. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Mathys Orthopaedics is recommending that surgeons inform affected patients implanted with an x/5 inlay about the higher than anticipated occurrence rate of PE inlay breakage and the associated potential risks while maintaining their routine follow-up protocol for patients who have undergone knee 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 patients’ clinical circumstances. For more information, please see https://www.tga.gov.au/alert/balansys-uni-convex-pe-inlays-x5-used-knee-replacements . This action has been closed-out on 26/05/2017. |
| Contact Information |
02 9417 9200 - Mathys Orthopaedics |