Events

Retiro De Equipo (Recall) de LCS COMPLETE RPS Knee System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

¿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-2015-RN-00223-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-24
  • 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-2015-RN-00223-1
  • 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
    Jjm was recently notified by the therapeutic goods administration (tga), that the lcs complete rps knee system has a higher rate of revision than the class of ps knee systems based on recent data from the aoanjrr. after further analysis of the aoanjrr data, depuy orthopaedics, inc (the manufacturer) determined that the lcs complete rps knee system has higher rates of revision in australia when the native patella is not resurfaced when compared to other unresurfaced ps implants. the need for a second surgery to resurface the native patella is due to an increased incidence of postoperative patello-femoral pain.
  • Acción
    Johnson & Johnson Medical is notifying surgeons of higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. Surgeons are advised that when using the LCS Complete RPS Knee System, the patella must be resurfaced. Johnson & Johnson Medical has also advised surgeons of the potential clinical implications for implanted LCS COMPLETE RPS Knee Systems where the native patella is not resurfaced.For further information https://www.tga.gov.au/alert/lcs-complete-rps-knee-system-used-knee-replacements. This action has been closed-out on 12/08/2016.

Device

LCS COMPLETE RPS Knee System

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes