Events

Notificaciones De Seguridad De Campo acerca de Hip, Knee and Shoulder products with a high polished surface packaged in LDPE (Low Density Polyethylene) pouches

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
    2016-01-25
  • 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
    This notification is a follow up to the correction notice provided in august 2013. at that time and after a thorough investigation into the cause of the issue, zimmer biomet implemented a change to package the highly polished implants with a new ldpe bag. testing has shown that this new bag resolves the issue and prevents the bag from adhering to the implants. nonetheless, zimmer biomet has continued to receive complaints that the old ldpe bag containing the implant adheres to the highly polished implant surface. the frequency of this occurrence is approximately 1 in 12,800 cases. accordingly zimmer biomet is removing the affected product remaining in the field. .

Device

Hip, Knee and Shoulder products with a high polished surface packaged in LDPE (Low Density Polyet...

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