Events

Retiro De Equipo (Recall) de Journey BCS Knee Replacement System - Femoral Implant

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew Surgical 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-2014-RN-00004-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-01-03
  • 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-2014-RN-00004-1
  • 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
    The femoral implant/tibial baseplate combination of the journey bcs knee system has been identified in the australian orthopaedic association’s national joint replacement registry (aoanjrr) as having a higher than expected revision rate when compared to all other primary total knee replacements.. the aoanjrr data indicates that journey bcs has a higher incidence of revisions due to patellofemoral pain, unspecified pain and instability. the most recent journey bcs knee system revision data published by the njrr include: - a revision rate of 1.59 (1.34, 1.88) revisions per 100 observed component years compared to 0.72 (0.70, 0.73) for other total knee replacements; and- a yearly cumulative percent revision of 7.0% (5.8, 8.4) at 5 years compared to 3.8% (3.7, 3.8) for other total knee replacements. smith & nephew is withdrawing the femoral implant component of the journey bcs knee system from the market.
  • Acción
    Smith and Nephew is recommending that surgeons contact their patients who have been implanted with the Femoral Implant component as part of a primary knee replacement surgery and inform them of the current alert. Surgeons are advised to maintain standard follow-up protocols and actions for the care of their patients. Smith and Nephew do not recommend pre-emptive removal. Revision should only be undertaken when there are symptoms related to implant failure. JOURNEY BCS will no longer be available as a primary knee replacement system. The UHMWPE inserts of the JOURNEY BCS Knee System continues to be available for revision use. For more information, please see http://www.tga.gov.au/safety/alerts-device-journey-bcs-knee-replacement-system-140106.htm .

Device

Journey BCS Knee Replacement System - Femoral Implant

Manufacturer

Smith & Nephew Surgical Pty Ltd