Events

Alerta De Seguridad para DePuy ADEPT 12/14 Modular Head

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

¿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
    2013-01-22
  • Fecha de publicación del evento
    2013-01-22
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130122c.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 adept 12/14 modular head the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning adept 12/14 modular head, manufactured bydepuyorthopaedics(a johnson & johnson company). review of post‐market surveillance data suggests a higher than expected revision rate for the adept 12/14 modular head when used in conventional total hip arthroplasty. analysis of uk national joint registry supplier feedback data indicates a cumulative revision rate of 12.1% (95% ci 9.5% to 15.4%) at 7 years for the affected product when used in conventional total hip arthroplasty. in september 2012, the australian orthopaedic association national joint replacement registry reported a cumulative revision rate of 7.1% (95% ci 3.6% to 13.6%) at 3 years with 8 revisions in a cohort of 121 adept 12/14 modular head cases used in conventional total hip arthroplasty. the manufacturer advises that patients who have received the affected products should be followed according to local guidance/standard of care for patients receiving metal on metal (mom) articulations. also, refer to the local orthopaedic association for detailed information related to the treatment of patients with mom articulations. for details, please refer to mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con224428 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 january 2013.

Device

DePuy ADEPT 12/14 Modular Head
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: DePuy ADEPT 12/14 Modular Head
  • Manufacturer
    DePuyOrthopaedics

Manufacturer

DePuyOrthopaedics