Alerte De Sécurité sur Metal-metal prostheses

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par N/A.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1230
  • Date
    2013-02-07
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    1. The ANVISA Technovigilance Unit is following the discussions; 2. the registry holders of products in Brazil were contacted, who informed that they did not receive complaints involving their products; 3. The NOTIVISA database, adverse event notification or technical complaint involving this technology has not been included so far; 4. Publication available on the FDA website on the internet reinforces some of the care already applied to patients who need implants or who have undergone orthopedic implant surgeries: (i). To choose the type of implant, a physician should choose to use a metal-to-metal hip implant only after determining that the benefit-risk of using one metal to metal exceeds the use of another type of technology; (ii). Patients implanted should be monitored periodically, through physical and imaging exams; (iii). The decision to review a metal-to-metal hip implant should be made according to the patient's clinical situation.
  • Cause
    News published by foreign bodies, including regulators, point to the possibility of adverse events associated with the use of metal-metal prostheses. the friction of the metal can cause particle release and consequent wear of the device and thus cause damage to the surrounding bone and / or soft tissues. such damage can result in pain, loosening of the implant and need for surgical revision procedure. it is also being raised the possibility of release of ions into the bloodstream, which would cause systemic damage. according to the fda, there is currently insufficient scientific data to specify the concentration of metal ions in a patient required to produce systemic adverse effects. in addition, the reaction appears to be patient-specific.
  • Action
    SAFETY ALERT

Device

  • Modèle / numéro de série
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA