Events

Alerta De Seguridad para Cemented, Polished and Cobalt Chromium Alloy Hip Stems

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

¿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
    2012-05-03
  • Fecha de publicación del evento
    2012-05-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120503f.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 cemented, polished and cobalt chromium alloy hip stems it comes to our attention that medical device manufacturer, depuy (a johnson & johnson company) has issued a field safety notice concerning depuy cemented, polished and cobalt chromium alloy hip stems. in 2007, depuy issued a letter to ultima tps cemented polished cobalt chromium (cocr) hip stem users in the united kingdom (uk) to inform them of a potential association between extensive peri-prosthetic soft tissue necrosis and hip stem implantation with the ultima metal-on metal (mom). following research activities undertaken by depuy, it was concluded that when used in combination with a mom articulation of an all metal type, depuy’s cemented, polished, cocr femoral hip stems, including the depuy g2 and fjord cemented femoral hip stems could potentially exhibit corrosion of the polished surfaces which are within the cement mantle. this corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. therefore, depuy advises against the implantation of the following configuration: depuy’s cemented, polished, cocr alloy femoral hip stems combined with mom articulation. according to the local supplier, ultima tps, depuy g2 and fjord cemented femoral hips stems have not been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted 03 may 2012.

Device

Cemented, Polished and Cobalt Chromium Alloy Hip Stems
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: DePuy Cemented, Polished and Cobalt Chromium Alloy Hip Stems
  • Manufacturer
    DePuy

Manufacturer

DePuy