Events

Retiro De Equipo (Recall) de Active Knee System - Patella Insert (Used as a component in total knee replacement) ASDM

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Advanced Surgical Design & Manufacture Limited.

¿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-01164-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-27
  • 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-01164-1
  • 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
    Advanced surgical design and manufacture has become aware of elevated failure rates of the patella component of the active knee system, specifically related to the shearing of the pegs. fourteen occurrences have been reported to date, which represents a failure rate of 0.7% of patellae implanted since july 2007. batches which have been found to be affected were manufactured between 2007 and 2011, with failures presenting between 1 to 4 years after implantation.Electron microscopy of the failed patella has shown that the patella pegs are failing due to fatigue. the initiation site for the fatigue failure appears to be a small overhang artefact, between 10 to 30 microns in depth, at the base of the patella peg. this small artefact may lead to elevated stresses at the base of the peg, and therefore increases the risk of premature product failure.
  • Acción
    Advanced Surgical Design and Manufacture is advising implanting/treating surgeons on how to manage patients implanted with the affected Active Knee System. For more details, please see http://www.tga.gov.au/safety/alerts-device-active-knee-121205.htm This action has been closed-out on 12/04/2016.

Device

Active Knee System - Patella Insert (Used as a component in total knee replacement) ASDM
  • Modelo / Serial
    Active Knee System - Patella Insert (Used as a component in total knee replacement) ASDM Part Number: 10-1514-075XLots manufactured prior to June 2012ARTG Number:133900
  • Manufacturer
    Advanced Surgical Design & Manufacture Limited

Manufacturer

Advanced Surgical Design & Manufacture Limited