Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par Advanced Surgical Design and Manufacture.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 050 12 12 000
  • Date de mise en oeuvre de l'événement
    2012-12-09
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=2713
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    Asdm is aware of elevated failure rates of the patella component of the active knee system, specifically related to the shearing of the pegs. electron microscopy of the failed patella has shown that the pegs are failing due to fatigue. the initiation site for the fatigue failure point appears to be a small overhang artefact, between 10 to 30 microns in depth, at the base of the patella peg. this small artefact may lead to elevated stresses at the base of the peg, and therefore increase the probability of premature product failure.

Device

Prosthesis, internal, joint, knee, total - Patella, Active Knee – Patella component
  • Modèle / numéro de série
    ARTG Number (ASDM Part Number, Lots Affected): 133900 (10-1514-075X, Lots manufactured prior to June 2012)
  • Description du dispositif
    Prosthesis, internal, joint, knee, total - Patella
  • Manufacturer
    Advanced Surgical Design and Manufacture

Manufacturer

Advanced Surgical Design and Manufacture