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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 Mathys Orthopaedics Pty Ltd
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 . This action has been closed-out on 26/05/2017.
Contact Information 02 9417 9200 - Mathys Orthopaedics