Events

Rappel de balanSys UNI convex PE inlay x/6, x/7, x/9

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Mathys Orthopaedics Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00096-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-02-14
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00096-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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