Events

Retiro De Equipo (Recall) de CONSERVE Shell, DYNASTY Metal Liner, RIM-LOCK Metal Liner, LINEAGE Metal Liner (components used for Metal on Metal (MoM) Total Hip Arthroplasty)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por MicroPort Orthopedics 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-00893-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-02
  • 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-00893-1
  • 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 orthopedics inc.’s international experience has shown an increasing overall trend in revisions from 2009 to present, and it was identified that there was a specific hazard/harm for “suspected tissue reaction to metal debris”. the potential for a patient reaction when implanted with metal on metal tha is a known risk for this product technology. the typical impairment of tissue reaction is reversed by revision surgery to remove the old device and replace it with a new device.Microport metal on metal total hip replacements have not been used in australia since 2013 and have been cancelled from the australian register of therapeutic goods (artg). in australia, published information has shown few users with low revisions. for more information, please see https://www.Tga.Gov.Au/alert/microport-orthopedics-metal-metal-hip-implant-components .
  • Acción
    MicroPort Orthopedics is contacting surgeons to make them aware of this issue. Rising levels in serial measurements of Cobalt and Chromium in blood, in conjunction with X-ray, MRI and ultrasound can be valuable in the follow-up of patients. Recipients of Total Conventional MoM implants with a large femoral head, and recipients of Total Resurfacing Implants who are female and/or have a small femoral head are at a higher risk of metal pathology related complications leading to revision. These patients should receive particularly close follow-up. The TGA has developed guidelines for the follow up of patients that have received a MoM hip replacement. These guidelines were developed in consultation with the Australian Orthopaedics Association and The Orthopaedics Sub Committee of the Advisory Committee on the Safety of Medical Devices, and can be found at: https://www.tga.gov.au/metal-metal-hip-replacement-implants .

Device

CONSERVE Shell, DYNASTY Metal Liner, RIM-LOCK Metal Liner, LINEAGE Metal Liner (components used f...
  • Modelo / Serial
    CONSERVE Shell, DYNASTY Metal Liner, RIM-LOCK Metal Liner, LINEAGE Metal Liner (components used for Metal on Metal (MoM) Total Hip Arthroplasty)All implanted lots
  • Manufacturer
    MicroPort Orthopedics Pty Ltd

Manufacturer

MicroPort Orthopedics Pty Ltd
  • Source
    DHTGA