Events

Retiro De Equipo (Recall) de Score Extension Stem for Total Knee Prosthesis - Cemented

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Amplitude Australia 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-2016-RN-00706-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-10
  • 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-2016-RN-00706-1
  • 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
    Amplitude has become aware through transport simulation tests that the packaging pouches of some devices could be damaged. the pouches function as the sterile barrier of the device packaging. there is a risk of infection if a patient is implanted with a non- sterile implant. the implantation of non-sterile device is unlikely. the routine tests conducted on devices did not show any case of non-sterility and no clinical incident was reported in relation with loss of sterility of the device.
  • Acción
    Amplitude is advising users to inspect stock and quarantine any remaining units of the affected products for return. Patients with implanted devices should be followed up as per standard hospital procedures.

Device

Score Extension Stem for Total Knee Prosthesis - Cemented
  • Modelo / Serial
    Score Extension Stem for Total Knee Prosthesis - CementedMultiple product codes affectedAll lot numbers affectedARTG number: 242001
  • Manufacturer
    Amplitude Australia Pty Ltd

Manufacturer

Amplitude Australia Pty Ltd