Events

Retiro De Equipo (Recall) de Glenosphere Orientation Guide Instrument used with the Delta EXTEND Reverse Shoulder 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 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-00552-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-30
  • 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-00552-1
  • 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
    Johnson and johnson has identified that the arrow used for eccentric glenosphere orientation is etched on the wrong side of the glenosphere guide instrument. using the wrong side of the guide instrument could result in the misalignment of the eccentric glenosphere with the superior and proximal portion of the shoulder blade.
  • Acción
    Surgeons are being advised of the clinical implications of incorrect implant orientation, including the potential for revision surgery. JJM does not recommend the prophylactic revision in the absence of symptoms. For more details, please see http://www.tga.gov.au/safety/alerts-device-glenosphere-orientation-guide-130607.htm .

Device

Glenosphere Orientation Guide Instrument used with the Delta EXTEND Reverse Shoulder System.

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia