Events

Alerta De Seguridad para Radial Head Prosthesis System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por DePuy Synthes.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2017-01-10
  • Fecha de publicación del evento
    2017-01-10
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170110c.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: depuy synthes radial head prosthesis system medical device manufacturer, depuy synthes, has issued a medical device safety alert concerning the removal of its radial head prosthesis system. the entire depuy synthes radial head prosthesis system is affected by this removal, however it is the radial stem that has the possibility of loosening post-operatively at the stem bone interface. based on the currently available data, the manufacturer believes the cause to be multifactorial (including possible product characteristics, operative and patient factors), but they have not been able to fully characterize these factors. consequently, the manufacturer has not been able at this time to issue further instructions to surgeons that might lead to a reduction in issue rate and has decided to remove the depuy synthes radial head prosthesis stem from the global market. health care practitioners that have treated patients using the affected products should continue to follow those patients in the usual manner. according to the manufacturer, if the radial stern becomes loose post-operatively, the following may occur: device loosening, osteolysis, poor joint mechanics, pain, bone fracture - post-operatively, and soft tissue damage (soft tissue irritation). the manufacturer is requesting users to immediately review their inventory to identify and quarantine all affected products listed above in a manner that ensures the affected products will not be used. the affected products should be returned to the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 10 january 2017.

Device

Radial Head Prosthesis System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: DePuy Synthes Radial Head Prosthesis System
  • Manufacturer
    DePuy Synthes

Manufacturer

DePuy Synthes