Events

Alerta De Seguridad O Notificaciones De Seguridad para Orthopaedic implant rHead Radial Head and Uni-Elbow

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Stryker.

¿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
    Safety alert / Field Safety Notice
  • Fecha
    2019-02-08
  • Fecha de publicación del evento
    2019-02-08
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/orthopaedic-implant-rhead-radial-head-and-uni-elbow-risk-of-early-loosening-mda-2019-006
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
    Stryker issued a Field Safety Notice dated November 2017 informing clinicians of the recall of the rHead Radial Head and Uni-Elbow prosthesis. The manufacturer identifies the possibility of post-operative implant loosening (septic and aseptic), instability (moderate/severe), stress fracture (bone), cyst formation (bone resorption), stiffness, pain, impingement, heterotopic ossification with these devices.This Medical Device Alert is being issued to ensure that all hospitals are aware of the issue and that adequate action is taken to mitigate potential risk to patients.
  • Causa
    Manufactured by stryker – post-operative loosening of the implant which may require revision surgery.
  • Acción
    Do not implant these devices (see details below) Identify and quarantine all affected devices Identify and advise all patients implanted with affected devices to contact their orthopaedic surgeon if they develop symptoms such as pain, loss of function or instability. Follow actions recommended in the manufacturer’s Field Safety Notice Report all adverse events involving this device to Stryker and through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales.

Device

Orthopaedic implant rHead Radial Head and Uni-Elbow
  • Modelo / Serial
  • Descripción del producto
    All lots of the Stryker rHead Radial Head and Uni-Elbow are affected.The manufacturer’s Field Safety Notice has details of the affected part numbers.
  • Manufacturer
    Stryker

Manufacturer

Stryker
  • Dirección del fabricante
    Stryker GmbH c/o Stryker T&E Post Market Safety Bohnackerweg 1 CH – 2545 Selzach SwitzerlandTel: +41 (0)79 904 3871tnepfa@stryker.com
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    MHRA