Events

Retiro De Equipo (Recall) de ABGII Modular Stems and ABGII Modular Necks (An exchangeable modular neck, designed to allow intra-operative flexibility for bio mechanical adjustment of offset and anteversion without affecting leg length)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker 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-2012-RN-00493-3
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-07-06
  • 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-00493-3
  • 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
    This action is occurring worldwide because of a high incidence of wear, known as fretting and corrosion, at the join between the femoral stem and the neck component. fretting and corrosion can result in metal debris in and around the hip joint. if this occurs, patients may experience inflammation, adverse local tissue reactions (altrs), hypersensitivity/allergic reactions and osteolysis (bone loss).
  • Acción
    The ABGII Modular Femoral Stem and Modular Neck has been cancelled from the Australian Register of Therapeutic Goods (ARTG). Stryker Australia Pty Ltd has contacted orthopaedic surgeons who has ever implanted the ABGII modular hip replacement system. Those surgeons have been asked to contact their patients to discuss what clinical action is most appropriate. For more details, please see https://www.tga.gov.au/alert/abgii-modular-femoral-stem-and-modular-neck-hip-replacement-system and https://www.tga.gov.au/alert/abgii-modular-femoral-stem-and-modular-neck-hip-replacement-system-update .

Device

ABGII Modular Stems and ABGII Modular Necks (An exchangeable modular neck, designed to allow intr...
  • Modelo / Serial
    ABGII Modular Stems and ABGII Modular Necks (An exchangeable modular neck, designed to allow intra-operative flexibility for bio mechanical adjustment of offset and anteversion without affecting leg length) Multiple Catalogue NumbersAll lot numbersARTG Number: 145647
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA