Events

Recall of balanSys UNI convex PE inlay x/6, x/7, x/9

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-2018-RN-00096-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-02-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00096-1
  • 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
    Global post market surveillance data showed two (2) reports from 2016 and 2017 concerning in situ inlay breakage of balansys uni convex pe inlays x/6 after approximately eight years. in 2015 mathys ltd bettlach made the decision to phase-out the balansys uni convex unicompartmental knee system based on economic grounds, with only the uni convex pe inlays to be retained to allow for potential minor revision surgeries. the phase out was initiated in december 2015, and completed by december 2016. in november 2016, a field safety corrective action was carried out to recall all balansys uni convex pe inlays x/5 (thickness 5 mm) from the market after the occurrence of seven (7) breakages of the inlays x/5. no events have been reported for x/7 and x/9.
  • Action
    Mathys Orthopaedics is advising surgeons to inform affected patients implanted with a size x/6, x/7 and x/9 inlay about the risks of PE inlay breakage and any further associated potential risks while maintaining their routine follow-up protocol. The need for any additional follow-up or revision surgery should be determined on a case-by-case basis following a detailed assessment of each patients’ clinical circumstances.

Device

balanSys UNI convex PE inlay x/6, x/7, x/9
  • Model / Serial
    balanSys UNI convex PE inlay x/6, x/7, x/9Multiple affected Art Numbers - all lots of these are affectedARTG Number: 212828 - cancelled
  • Manufacturer
    Mathys Orthopaedics Pty Ltd

Manufacturer

Mathys Orthopaedics Pty Ltd