Events

Recall of Birmingham HIP Total Modular Head Hip Prosthesis;Birmingham HIP Modular Head (BHMH)

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Smith & Nephew.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    201503987
  • Date
    2015-04-02
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    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
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Action
    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)
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Smith & Nephew

Manufacturer

Smith & Nephew