Events

Retiro De Equipo (Recall) de Birmingham Hip Modular Head (Used as part of a Total Conventional Hip Replacement 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 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-2012-RN-00988-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-10-02
  • 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-00988-1
  • 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 birmingham hiptm modular head (bhmh) as part of a total conventional hip replacement system has been identified in the australian national joint replacement registry (njrr) and the national joint registry of england and wales (njrew) as having a higher than expected revision rate when compared to all other total conventional hip replacements. in addition, most of the revisions that are occurring later (after the third year) are linked to metal sensitivity and infection.
  • Acción
    Smith & Nephew is advising implanting/treating surgeons on how to manage patients implanted with the Birmingham Hip Modular Heads. For more information, please see http://www.tga.gov.au/safety/alerts-device-hip-bhmh-121030.htm

Device

Birmingham Hip Modular Head (Used as part of a Total Conventional Hip Replacement system)
  • Modelo / Serial
    Birmingham Hip Modular Head (Used as part of a Total Conventional Hip Replacement system)Part Numbers : 121238 – 121258, 121338 – 121558, 74121238 – 74121558 & 74222138 – 74222162 All Batches ARTG Number: 124100
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd