Events

Alerta De Seguridad para Apex K2 Femoral Stem

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

¿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_20121101a.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: omnilife science apex k2 femoral stem the therapeutic goods administration (tga), australia issued a medical device alert concerning apex k2 femoral stem, manufactured by omnilife science, inc. (global orthopaedic technology as the sponsor in australia) the tga advised health professionals and patients that global orthopaedic technology has cancelled the apex k2 femoral stem from the australian register of therapeutic goods. the decision to cancel was based on an analysis of data collected by the australian national joint replacement registry (njrr), which revealed that the apex k2 femoral stem had a higher than expected revision rate. the 2012 australian njrr report indicated that the cumulative revision rate for the apex k2 modular hip replacement system was 5.5% at 1 year from the time of implantation and 9.3% at 3 years. a headline revision rate of 4.6 revisions per 100 observed years compared to 1.6% at 1 year and 2.8 % at 3 years from implantation and a headline revision rate of 0.81 revisions per 100 observed years for all other total conventional hip replacements. for details, please visit the following tga website: http://www.Tga.Gov.Au/safety/alerts-device-hip-apex-k2-121030.Htm if you are in possession of the products, please contact your supplier for necessary actions. posted on 1 november 2012.

Device

Apex K2 Femoral Stem
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: OMNILife science Apex K2 Femoral Stem
  • Manufacturer
    OMNILife science

Manufacturer

OMNILife science