Events

Alerta De Seguridad para Full name: System for total femoral-tibial-patellar multi-compartment total arthroplasty ANVISA registration number: 80102511373 Hazard class: III Affected model: Ceramic alumina heads 36 mm Series numbers affected: 0211313520; 0311327277; 0311337209; 1555038; 1648756; 1650634; 1633531; 1648754; 1602583; 1655960; 1668359; 1655972; 1655960; 1648759; 1655972; 15541511687588; 15546491621617; 14519031660611; 1555037; 1684826; 1633530; 1656049; 0656748101; 016316886; 065: 05810312; 085: 05810102; 0557332101; 0657633801; 0556748101; 1648801.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; MICROPORT ORTHOPEDICS INC..

¿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
  • ID del evento
    2211
  • Fecha
    2017-03-06
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Product purchasers should immediately: evaluate their inventory and segregate related parts for product return, which will be forwarded to the manufacturer. Conduct to be taken in cases where the implant has already been implanted: MicroPort Orthopedics recommends that surgeons maintain their protocol and the standard follow-up measures in their patients and ensure that patients are informed of the symptoms (in particular, pain, instability, difficulty walking and / or performing common tasks) that indicate the need for revision surgery. Any adverse events or doubts should be reported to the registry holder in Brazil via email or telephone so that the manufacturer is activated and the health authorities are also informed.
  • Causa
    The action voluntary retrieval of biolox forte 36mm alumina ceramic heads belonging to the record 80102511373 was started because the implants will be updated with a label indicating the numeric offset of the ceramic head instead of the label currently used which indicates (short, medium, long ), because during a microport investigation the biolox forte 36 mm alumina ceramic head was confirmed to be about 2 mm smaller than other microport 36 mm femoral heads (cobalt chrome and biolox delta femoral heads).
  • Acción
    Field Action Code AC0317 triggered under the responsibility of the company VR MEDICAL IMPORTADORA AND DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA. Company will collect.

Device

Full name: System for total femoral-tibial-patellar multi-compartment total arthroplasty ANVISA r...

Manufacturer

VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; MICROPORT ORTHOPEDICS INC.
  • Source
    ANVSANVISA