Events

Retiro De Equipo (Recall) de Cementless Columbus Knee System Multiple components

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por B Braun Australia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-00637-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-06-27
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00637-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Cementless Columbus Knee System Multiple componentsARTG Number: 96481
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd