Events

Notificaciones De Seguridad De Campo acerca de Oxford cementless prosthetic knee prosthesis system

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Zimmer Biomet.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2017-03-28
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    An analysis showed 0.12% of cases in patients worldwide who had fractures of the tibial plateau. an analysis of reported complaints has yielded results showing that, in the event of a fracture, tibia was identified by the orthopedic surgeon on average 25 days after the primary surgery, and available data indicates that 17% of these fractures were treated conservatively. the cementless oxford tibial trays were manufactured according to predefined specifications. an investigation into the cause of reported tibial plateau fractures has shown that it is important to follow certain steps outlined in current surgical techniques to reduce the risk of tibial plateau fractures. this notice seeks to emphasize the importance of adhering to the applicable surgical technique and the relevant sections in the package leaflet.

Device

Oxford cementless prosthetic knee prosthesis system
  • Modelo / Serial
    Article Number Batch numbers 166570, 166571, 166845, 166846, 166572, 166573, 166574, 166575, 166576, 166577, 166578, 166579, __ 166580, 166581 V39 serue 154913,154914,154915,154916,154917,154918, 154919,154920,154921,154922,154923,154924 \ lse serue USl66570, U5166571, U3166845, U5166846, U5166572, USl66573, USl66574, U5166575, U5166576, USl66577, U5166578, U5166579, \ lse serue U5166580, U5166581
  • Manufacturer
    Zimmer Biomet

Manufacturer

Zimmer Biomet
  • 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
    AMPMDRS