Events

Notificaciones De Seguridad De Campo acerca de seleXys TH+ and seleXys TPS shells

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 Mathys Ltd Bettlach.

¿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
    2015-09-15
  • 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
    A recent analysis of data derived from the australian orthopaedic association national joint replacement registry (aoanjrr) shows that the revision rates for the selexys th+ and selexys tps acetabular shells are higher than the revision rate of other acetabular cups/shells being used in australia. the aoanjrr identifies loosening/lysis as the most significant reasons for revisions of the selexys th+ and tps shells. it is important to note that this field safety notice does not relate to the selexys pc acetabular shells which continue to have a satisfactory, equivalent revision rate when compared with other total hip replacement systems. .

Device

seleXys TH+ and seleXys TPS shells
  • Modelo / Serial
    55.42.0142 seleXys TH+ shell 42/AA all 55.42.0144 seleXys TH+ shell 44/BB all 55.42.0146 seleXys TH+ shell 46/CC all 55.42.0148 seleXys TH+ shell 48/DD all 55.42.0150 seleXys TH+ shell 50/EE all 55.42.0152 seleXys TH+ shell 52/FF all 55.42.0154 seleXys TH+ shell 54/GG all 55.42.0156 seleXys TH+ shell 56/HH all 55.42.0158 seleXys TH+ shell 58/II all 55.42.0160 seleXys TH+ shell 60/JJ all 55.42.0162 seleXys TH+ shell 62/KK all 55.42.0164 seleXys TH+ shell 64/KK all
  • Manufacturer
    Mathys Ltd Bettlach

Manufacturer

Mathys Ltd Bettlach