Events

Alerta De Seguridad para Durom Acetabular Component

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Zimmer.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2012-11-01
  • Fecha de publicación del evento
    2012-11-01
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121101b.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: zimmer durom acetabular component the therapeutic goods administration (tga), australia issued a medical device alert concerning durom acetabular component, manufactured by zimmer. the tga advised health professionals and patients that zimmer has cancelled the implant from the australian register of therapeutic goods (artg). the decision to cancel was based on an analysis of data collected by the australian national joint replacement registry (njrr), which revealed that the implant had a higher than expected revision rate. the 2011 njrr report revealed that the durom acetabular component's cumulative revision rate was 9.6% at 7 years in resurfacing applications (compared to 6.1% for all other similar implants) and 6.8% at 5 years in total conventional hip replacements (compared to 3.6% for all other similar implants). for details, please visit the following tga website: http://www.Tga.Gov.Au/safety/alerts-device-hip-dac-121030.Htm if you are in possession of the products, please contact your supplier for necessary actions. posted on 1 november 2012.

Device

Durom Acetabular Component
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Zimmer Durom Acetabular Component
  • Manufacturer
    Zimmer

Manufacturer

Zimmer
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DH