Events

Retiro De Equipo (Recall) de Apex K2 Modular Hip Replacement System (total joint prosthesis)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Global Orthopaedic Technology 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-2012-RN-01012-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-18
  • 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-2012-RN-01012-1
  • 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 annual reports of the australian national joint registry [njrr], have indicated a higher than expected revision rate for this prosthesis since 2010. the 2011 njrr report indicated that the cumulative revision rate for the device was 5.2% at 1 year from the time of implantation, and a headline revision rate of 4.6 revisions per 100 observed years. the revision rate for the implant continues to be higher than that of similar implants being used in australia. the apex k2 stem has not been available for implantation since early october 2011.This device has now also been cancelled from the australian register of therapeutic goods as well as the private hospital prosthesis list.
  • Acción
    Global Orthopaedic Technology is advising implanting/treating surgeons on how to manage patients implanted with Apex K2 Femoral Stem. For more details, please see http://www.tga.gov.au/safety/alerts-device-hip-apex-k2-121030.htm

Device

Apex K2 Modular Hip Replacement System (total joint prosthesis)
  • Modelo / Serial
    Apex K2 Modular Hip Replacement System (total joint prosthesis)Multiple Catalogue NumbersPrevious ARTG Number: 149020
  • Manufacturer
    Global Orthopaedic Technology Pty Ltd

Manufacturer

Global Orthopaedic Technology Pty Ltd