Events

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

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-2016-RN-01502-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-12-02
  • 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-2016-RN-01502-1
  • 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
    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)
  • Modèle / numéro de série
    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