Events

Notificaciones De Seguridad De Campo acerca de DePuy Articular Surface Replacment System ASR Unipolar Femoral Implants, DePuy Articular Surface Replacment System Total ASR Acetabular Implants, DePuy Articular Surface Replacment System ASR Tapered Sleeve Adaptor

Según ALIMS (Agencija za lekove i medicinska sredstva), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Serbia que fue producido por De Puy International Limited.

¿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
    2010-08-24
  • Fecha de publicación del evento
    2012-01-30
  • País del evento
    Serbia
  • Fuente del evento
    ALIMSA
  • URL de la fuente del evento
    https://www.alims.gov.rs/latin/2012/01/30/povlacenje-medicinskog-sredstva-de-puy/
  • Notas / Alertas
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notas adicionales en la data
  • Causa
    After receiving new data from the uk that demonstrated the asr system had a higher than expected revision rate at 8-9 percent at three years when used with smaller head sizes (less than 50 mm diameter). the overall revision rate for asr continued to be in line with the class of metal-on-metal monoblock systems based on the data available to depuy at that time. depuy has just recevied new, unpublished 2010 data from the national joint registry (njr) of england and wales. the data shows the five year revision rate for asr hip resurfacing system is approximately 12 percent and for the asr xl acetabular system is approximately 13 percent. these revision rates are across the entire size range. the risk for revision was highest with asr head sizes below 50 mm in diameter and among female patiens.*do not implant the acr devices.

Device

DePuy Articular Surface Replacment System ASR Unipolar Femoral Implants, DePuy Articular Surface ...

Manufacturer

De Puy International Limited