Events

Retiro De Equipo (Recall) de ADEPT 12/14 Modular Head (Used as femoral head component in metal on metal (MoM) total hip arthroplasty)

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 Australia.

¿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-2013-RN-00054-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-02-25
  • 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-2013-RN-00054-1
  • 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
    Review of post-market surveillance data suggests a higher than expected revision rate for the adept® 12/14 modular head used in conventional total hip arthroplasty (tha). in september 2012 the aoa njrr reported a cumulative revision rate of 7.1% (95% ci 3.6% to 13.6%) at 3 years with 8 revisions in a cohort of adept® cases (adept® cups used in conjunction with adept® 12/14 modular heads) used in conventional total hip arthroplasty. the identified reasons for the revisions are 4 loosening/lysis, 2 infections, 1 prosthesis dislocation and 1 pain. an analysis of uk njr data (download 11th november 2012) indicated a cumulative revision rate of 12.1% (95% ci 9.5% to 15.4%) at 7 years for the adept® 12/14 modular head when used in conventional total hip arthroplasty based on 109 revisions from 1582 recorded procedures. when this combination is used with the adept® cementless stem, the data showed a cumulative revision rate of 9.7% (95% ci 5.9% to 15.5%) at five years.
  • Acción
    J&J; is advising implanting/treating surgeons on how to manage patients implanted with the Adept 12/14 Modular Head. For more information, please see http://www.tga.gov.au/safety/alerts-device-hip-ahm-130318.htm .

Device

ADEPT 12/14 Modular Head (Used as femoral head component in metal on metal (MoM) total hip arthro...

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia