Events

Rappel de Cementless Columbus Knee System Multiple components

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par B Braun Australia 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-2013-RN-00637-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-06-27
  • 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-2013-RN-00637-1
  • 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
    B. braun is withdrawing the cementless version of the columbus knee system from the australian register of therapeutic goods (artg) and is issuing a hazard alert to implanting surgeons. the decision to withdraw the cementless version of the columbus knee system was based on an analysis of data collected by the australian national joint replacement registry (njrr), which revealed that the cementless columbus knee system had a higher than acceptable revision rate.The cumulative revision rate (including all 33 revisions) for the cementless columbus knee system is 2.7% (95% ci: 1.6, 4.6) at one year from the time of implantation, 6.9% (95% ci: 4.8, 9.7) at three years, and 7.5% (95% ci: 5.3, 10.5) at five years, respectively, which is higher compared to all other total knee replacements with a cumulative revision rate of 1.0% (95% ci: 1.0, 1.0) at one year from the time of implantation, 2.7% (95% ci: 2.7, 2.8) at three years, and 3.6% (95% ci: 3.6, 3.7) at five years.
  • Action
    Given the nature of the problem, orthopaedic surgeons are advised that there is no need to contact patients who have received an cementless Columbus Knee System additionally in addition to regular examinations; however, it is recommended that implanting surgeons conduct regular clinical and radiological examinations on those patients, in accordance with routine patient post-arthroplasty care, and advise them of this issue at that stage. For more details, please see http://www.tga.gov.au/safety/alerts-device-columbus-knee-system-130709.htm

Device

Cementless Columbus Knee System Multiple components
  • Modèle / numéro de série
    Cementless Columbus Knee System Multiple componentsARTG Number: 96481
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd