Events

Retiro De Equipo (Recall) de PROFEMUR NECK VAR/VAL 8DG, Long Cobalt Chrome, Part number PHAC1254(Modular neck component of the femoral head/stem prosthesis)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Wright Medical 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-2015-RN-00737-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-19
  • 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-2015-RN-00737-1
  • 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
    Microport orthopaedics inc. has identified unanticipated postoperative implant fractures related to this specific part number. these fractures are extremely rare, yet there have been 27 reports (failure rate of 0.275%) of fracture of the phac1254 component. all fractures involve part number phac1254 (long 8-degree varus) which sees the highest bending force due to its length and therefore represents the implant in this product family with the lowest mechanical strength under clinical conditions. no implant fractures have been reported in other pro femur cocr modular neck models. in the event the modular neck fractures, the patient may experience sudden pain, instability and difficulty walking/performing common tasks.
  • Acción
    Surgeons are advised that there is no evidence fractures can be anticipated by visual inspection or during surgery. When the modular neck fractures, the patient may experience sudden pain, instability and difficulty walking/performing common tasks. A break will require revision surgery to correct. Should a patient present with sudden pain, instability and difficulty walking/performing common tasks a postoperative fracture can be confirmed via x-ray. No additional patient follow-up is required however surgeons are advised to discuss the issues with their patients . This action has been closed-out on 04/05/2017.

Device

PROFEMUR NECK VAR/VAL 8DG, Long Cobalt Chrome, Part number PHAC1254(Modular neck component of the...
  • Modelo / Serial
    PROFEMUR NECK VAR/VAL 8DG, Long Cobalt Chrome, Part number PHAC1254(Modular neck component of the femoral head/stem prosthesis) All lot numbersARTG number: 234443
  • Manufacturer
    Wright Medical Australia Pty Ltd

Manufacturer

Wright Medical Australia Pty Ltd