Alerte De Sécurité sur prosthesis for joint replacement

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Hoffmann S.R.L || Smith & Nephew Orthopaedics Ag || Aap Biomaterials Gmbh || Smith & Nephew, Inc || Straits Orthopaedics (Mfg) Sdn. Bhd || Medicalplastic.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
  • Numéro de l'événement
  • Date
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données


  • Modèle / numéro de série
    Concerning the product R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM reference || 71339548, lot 15LM07776.
  • Description du dispositif
    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