Events

Recall of Cementless Columbus Knee System Multiple components

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by B Braun Australia 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-2013-RN-00637-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-06-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00637-1
  • 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
    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
  • Model / Serial
    Cementless Columbus Knee System Multiple componentsARTG Number: 96481
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd