Events

Retiro De Equipo O Alerta De Seguridad para ASR XL Acetabular System & DePuy ASR Hip Resurfacing system

Según Central Drugs Standard Control Organization, este evento ( retiro de equipo o alerta de seguridad ) involucró a un dispositivo médico en India que fue producido por DePuy International Limited.

¿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
    Recall / Safety Alert
  • ID del evento
    31-132-MD/2006-DC (Re. Reg. 2009)
  • Fecha
    2013-12-09
  • País del evento
    India
  • Fuente del evento
    CDSCO
  • URL de la fuente del evento
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • Notas / Alertas
    The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, 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 India.
  • Notas adicionales en la data
  • Causa
    Recall of asr hip replacement implants due to increased rates of revision.
  • Acción
    - Do not implant DePuy ASR hip replacements. - Return all unused ASR hip replacement implants to the manufacturer. - Inform all patients implanted with ASR hip replacements about this recall and schedule them for a follow-up visit. - Follow up all patients implanted with ASR hip replacements with clinical examination at least annually. - For patients presenting with symptoms of abnormal pain, limping, swelling around the hip, deteriorating hip function or radiological abnormality: * consider measuring cobalt and chromium ion levels in whole blood and/or performing cross sectional imaging including MRI or ultrasound scan. * If metal ion levels in whole blood are elevated above 120 nmol/L (cobalt) or 135 nmol/L (chromium) [ie seven parts per billion (ppb) for either metal ion], a second test should be performed three months after the first in order to identify patients who require closer surveillance, which may include cross sectional imaging. * If MRI or ultrasound scan reveals soft tissue reactions, fluid collections or tissue masses then consider revision surgery.

Device

ASR XL Acetabular System & DePuy ASR Hip Resurfacing system

Manufacturer

DePuy International Limited