Events

Alerta De Seguridad O Notificaciones De Seguridad para DePuy Synthes Radial Head elbow prosthesis system

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 Synthes GmbH.

¿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
    2017-06-12
  • Fecha de publicación del evento
    2017-06-12
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/depuy-synthes-radial-head-elbow-prosthesis-system-risk-of-post-operative-loosening-of-the-radial-stem
  • 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
    In December 2016, DePuy-Synthes issued a Field Safety Notice informing clinicians of the recall of the Radial Head prosthesis due to the possibility of post-operative loosening of the stem at the stem-bone interface. Implant loosening may lead to osteolysis, poor joint mechanics, bone fracture or soft tissue damage.The radial stem was introduced into the UK market in 2015 and up to the publication date of this medical device alert, MHRA has received no reports of stem loosening.
  • Causa
    Manufactured by synthes gmbh - recall of radial head prosthesis system. associated radial head prosthesis system parts also need to be returned to depuy synthes but will be available for revision surgeries of the radial head component.
  • Acción
    Do not implant these devices (see details below). Locate and return all affected products to DePuy Synthes as detailed in their Field Safety Notice. 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. Consider monitoring patients at 6 monthly intervals for up to 2 years post-implantation, with both clinical and radiographic assessments (i.e. X-rays1) to identify possible loosening of the radial stem. Any asymptomatic patients identified with loosening of their implants should continue to be monitored at 6-monthly intervals for progressive osteolysis (including potential risk of fracture), or the development of symptoms needing revision surgery. Report all adverse events involving this device to DePuy Synthes and to MHRA or the appropriate Devolved Administration.

Device

DePuy Synthes Radial Head elbow prosthesis system
  • Modelo / Serial
  • Descripción del producto
    All lots of the DePuy-Synthes Radial Head prosthesis system are affected.For part number and description information for the device and associated parts refer to Attachment 1 of the manufacturer’s Field Safety Notice and the spreadsheet attached to this alert, which includes both catalogue numbers and relevant UDI Device Identifier codes (GS1 GTINs).
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH
  • Dirección del fabricante
    Martyn Kedie Johnson & Johnson Medical Ltd DePuy Synthes Leeds One St Anthony’s Road Leeds, LS11 8DTTelephone: 0113 387 6261Email: MDFieldActionsUKIrl@its.jnj.com
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    MHRA