Events

Retiro De Equipo (Recall) de SMF and MDF Modular Neck Hip Prosthesis Multiple products affected

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew 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-01649-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-12-22
  • 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-01649-1
  • 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
    During a recent review of product complaints received by smith & nephew and clinical study data associated with the modular hip prostheses, a rate of complaints higher than comparable monolithic hip prostheses was observed.Metal-related complaints are trending upward year-on-year with an overall complaint rate (number of complaints/total implantations) of 0.527% for modular smf and 0.25% for modular redapt revision femoral hip systems. overall, the metal-related adverse events accounted for the highest category of complaints in both products.
  • Acción
    Smith & Nephew is advising physicians to maintain their routine follow-up protocol for patients who have undergone total hip arthroplasty and continue to monitor for pain, swelling, limited mobility and enlarged bursa. For symptomatic patients, physicians may consider additional clinical follow-up. The need for any additional follow-up should be determined on an individual case-by-case basis following an assessment of patients’ clinical circumstances. Follow-up examinations should be repeated for symptomatic patients annually for the lifetime of the device to potentially help reduce the risk of complication and the need for additional surgery.

Device

SMF and MDF Modular Neck Hip Prosthesis Multiple products affected
  • Modelo / Serial
    SMF and MDF Modular Neck Hip Prosthesis Multiple products affectedPrevious ARTG Number: 101100
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd