Alerta De Seguridad para PFC KNEE SYSTEM - ANVISA Registration No. 10132590647 - Lots: 77217A, 81343A and 79709A

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por DEPUY ORTHOPAEDICS 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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    After gamma radiation, this vacuum sealing provides an oxygen-free environment for polyethylene, reducing its oxidation potential. Research indicates that prolonged natural aging of gamma-sterilized polyethylene in the presence of air can reduce long-term performance. It was determined that the loss of vacuum encountered only in a small percentage of the products occurred due to incomplete sealing resulting from the use of an unapproved sealing technique. The sealing of the outer carton is intact and therefore the sterility of the product has not been compromised. In addition to the corrective actions implemented, DePuy also began a comprehensive sampling of existing inventories to see if any other employee could have used unapproved techniques producing similar results. The final analysis of this sampling identified that another employee might be using a similar technique. Therefore, DePuy is expanding the scope of the initial recall to include other product and lot codes. These products are no longer being distributed and we believe most, if not all, of them have been deployed. In most cases, the natural aging time prior to the implant was relatively short and therefore the long-term performance impairment is minimal. No adverse events were found in products already implanted abroad.
  • Causa
    Vacuum loss in the inner laminate envelope.
  • Acción
    According to the company's internal traceability system, all products in stock and customers for which the products in question have been shipped have already been identified, and the field action communication has already been sent. The cause of incomplete sealing has been identified and is related to the specific batches being collected. Based on the sampling performed by DePuy Orthopedics, two per cent (2%) of the products from the collected lots may have incomplete sealing. The root cause of incomplete sealing was solved through improvements in inspection and process.


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