Events

Retiro De Equipo (Recall) de DePuy S-ROM Noiles Rotating Hinge Femur with Pin (compatible with the MBT revision tibial tray)

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-2014-RN-00355-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-03-26
  • 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-2014-RN-00355-1
  • 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 & johnson medical pty ltd has identified that there is potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for both the femur and the hinge pin, for all lots of depuy s-rom noiles rotating hinge femur with pin listed. the outer carton and shrink wrap are intact. the complaint rate for 2010 through 2013 is 0.35%. it is believed that these holes result from repeated shipments of the product in loan kits, over a number of years.
  • Acción
    The Operating Room staff/surgeon must be made aware of this potential issue. Prior to implantation, staff must inspect product packaging and if it is identified as having holes in one or both sterile pouches do not use the product and quarantine it. A second set of the DePuy S-ROM Noiles Rotating Hinge Femur with Pin will be sent to each case. S-ROM Noiles Rotating Hinge Femur with Pin devices without packaging breaches may continue to be used to avoid temporarily causing a sudden and complete lack of product availability and the bone loss associated with removing a well-fixed MBT Revision Tibial Tray. This action has been closed-out on 29/01/2016.

Device

DePuy S-ROM Noiles Rotating Hinge Femur with Pin (compatible with the MBT revision tibial tray)
  • Modelo / Serial
    DePuy S-ROM Noiles Rotating Hinge Femur with Pin (compatible with the MBT revision tibial tray)Product Codes: 623401L, 623401R, 623411L, 623411R, 623421L, 623421RAll lots numbers affectedARTG 219088
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia