Alerta De Seguridad para prosthesis for joint replacement

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Hoffmann S.R.L || Smith & Nephew Orthopaedics Ag || Aap Biomaterials Gmbh || Smith & Nephew, Inc || Straits Orthopaedics (Mfg) Sdn. Bhd || Medicalplastic.

¿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
  • Número del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data


  • Modelo / Serial
    Concerning the product R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM reference || 71339548, lot 15LM07776.
  • Descripción del producto
    They are designed for partial or total artificial replacement of the joints of the body such as: hip, knee, shoulder and elbow. Indicated for the treatment of complex cases of joints, osteoarthritis, instability of the articulation. Allowing to restore mobility, correct deformities in joints, reconstruction of joints, with specific clinical indications according to the articulation and reference. Among other indications for use, SMITH & NEPHEW replacement hip prostheses are used for the treatment of: • for people who are undergoing primary revision surgery where other treatments or devices have failed in the rehabilitation of the hip joints as a result of trauma or non-inflammatory joint degenerative disease (NIOJO) • any of its diagnoses composed of laosteoarthritis. • Avascular necrosis. • Traumatic arthritis. • Capital slippage of the epiphysis. • melted hip • fracture of the pelvis, and the diastrophic variant. • degenerative inflammatory disease of the joints including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia • old, remote osteomyelitis with a long syncretization period, in which case, the patient should be warned of a risk of infection above normal after the operation. • Treatments of fractures of: non-union, the neck and the trochanter, of the proximal femur with head involvement that are unmanageable using other techniques: endoprosthesis, femoral osteotomy or resection of GIRDLESTONE, • fracture with dislocation of the hip.
  • Manufacturer