Events

Recall of balanSys UNI convex polyethylene (PE) inlay x/5 (with thickness 5)(Unicondylar knee prosthesis)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Mathys Orthopaedics Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01502-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01502-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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 toprevent 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.
  • Action
    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.

Device

balanSys UNI convex polyethylene (PE) inlay x/5 (with thickness 5)(Unicondylar knee prosthesis)
  • Model / Serial
    balanSys UNI convex polyethylene (PE) inlay x/5 (with thickness 5)(Unicondylar knee prosthesis)balanSys UNI convex PE inlay A/5Item Number: 77.30.0211balanSys UNI convex PE inlay B/5Item Number: 77.30.0221balanSys UNI convex PE inlay C/5Item Number: 77.30.0231balanSys UNI convex PE inlay D/5Item Number: 77.30.0241balanSys UNI convex PE inlay E/5Item Number: 77.30.0251All Batch NumbersARTG Number: 212828
  • Manufacturer
    Mathys Orthopaedics Pty Ltd

Manufacturer

Mathys Orthopaedics Pty Ltd