Events

Retiro De Equipo (Recall) de Birmingham HIP Total Modular Head Hip Prosthesis;Birmingham HIP Modular Head (BHMH)

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Smith & Nephew.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    201503987
  • Fecha
    2015-04-02
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/chirurgie-orthopedique-prothese-totale-de-hanche-a-tete-modulaire-birmingham-hip-birmingham-hip-modular-head-bhmh-smith-nephew-information-de-securite
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    ANSM has been informed of the implementation of a safety action carried out by Smith & Nephew. The affected users have received the attached mail (02/04/2015) (119 KB). The ANSM reminds users of metal-to-metal friction hip prostheses that a warning to orthopedic surgeons and follow-up recommendations for patients carrying these implants have been published on its website. Risks related to metal-to-metal friction torque hip prostheses: Recommendations for use and monitoring of patients - Informatio Point. (17/12/2014) This safety action is registered with the ANSM under the number 201503987 .. You will be able to consult its progress report on the Directory of the signaling of materialovigilanc by entering this n ° of recording.

Device

Birmingham HIP Total Modular Head Hip Prosthesis;Birmingham HIP Modular Head (BHMH)
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Smith & Nephew

Manufacturer

Smith & Nephew