Events

Retiro De Equipo (Recall) de BIOLOX delta ceramic components Biolox Delta Modular Head and Trinity Ceramic Liner

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Corin 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-01518-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-18
  • 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-01518-1
  • 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
    Data from sources external to corin suggest that ceramic fragments from fractured ceramic components may remain in the joint following revision surgery, which can lead to premature wear of revision components if such revision components are made of non-ceramic materials. as a result, the instruction within the ifu for corin’s biolox delta ceramic components have been updated in respect of recommended actions in the case of revisions.
  • Acción
    The IFU is being revised to include the following information in the ‘Warnings & Precautions’ section: In the case of revision due to a fractured ceramic component, when keeping a well fixed stem, the modular head must be replaced with a Biolox Option modular head where available. If a Biolox Option modular head is not available, in addition to revising the modular head, the femoral stem must also be revised to provide a suitable taper to which a new ceramic femoral ball head can be attached. In the event of revision not due to fracture of a ceramic component, when keeping a well fixed stem, the modular head must be replaced with a metal modular head or a Biolox Option ceramic modular head only.

Device

BIOLOX delta ceramic components Biolox Delta Modular Head and Trinity Ceramic Liner
  • Modelo / Serial
    BIOLOX delta ceramic componentsBiolox Delta Modular Head and Trinity Ceramic LinerAll Part Number / Lot Codes ARTG Numbers: 211371 and 210774
  • Manufacturer
    Corin Australia Pty Ltd

Manufacturer

Corin Australia Pty Ltd