Retiro De Equipo (Recall) de S&N Journey Bi-Cruciate Stabilised femoral implant

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Smith & Nephew Inc.

¿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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Smith & Nephew Surgical Ltd, Unit A 36 Hillside road, Wairau Valley, AUCKLAND 0760
  • 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
    Manufacturer to issue advice regarding use