Events

Alerte De Sécurité sur Prosthesis System for Articular Replacements

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 manufacturer #121.

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
    I1510-479
  • Numéro de l'événement
    2012DM-0009024
  • Date
    2015-10-28
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=169
  • 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

Device

Prosthesis System for Articular Replacements
  • Modèle / numéro de série
    SeleXys Shell TH + and TPS, part number: 55.42.0142, 55.42.0144, 55.42.0146, 55.42.0148, 55.42.0150, || 55.42.0152, 55.42.0154, 55.42.0156, 55.42.0158, || 55.42.0160, 55.42.0162, 55.42.0164, 55.40.0042, || 55.40.0044, 55.40.0046, 55.40.0048, 55.40.0050, || 55.40.0052, 55.40.0054, 55.40.0056, 55.40.0058, || 55.40.0060, 55.40.0062, 55.40.0064.
  • Description du dispositif
    For the partial or total artificial replacement of the joints of the body such as: hip, knee, shoulder and for the treatment of complex cases, osteoarthritis, joint instability, allowing to restore mobility, correct deformities, joint reconstruction, specific clinical indications according to the articulation and model or reference. Prostheses for articular replacementMATHYS® of shoulder primary osteoarthritis, secondary osteoarthritis, rheumatoid arthritis, post-traumatic osteoarthritis, arthropathy with rotator cuff tear (hamada grade III or IV) in young patients, joint metabolic deficiency (eg, chondrocalcinosis, hemosiderosis, urate arthropathies ), sequelae of fractures (healing of humeral head fractures, healing sinussion / pseudoarthrosis, necrosis of the head, blocked dislocations), avascular necrosis of the head (if there are sufficient bones), poly-fragmentary fractures and comminution of the head of the humerus with danger of disorders in fragment vascularization, proximal humerus fractures not treatable by osteosynthesis, secondary dislocation of the fragments subsequent to osteosynthesis in the proximal humerus, rotator cuff arthropathy (RDA), revision of total prosthesis or failed semiprosthesis in patients with pathological rotator cuff, in certain tumorous modifications of the proximal humerus. MATHYS® Hip Joint Replacement Prosthesis: joint degenerative disease, such as primary or secondary coxarthritis, advanced loss of substance, and functional loss of the hip joint caused by degenerative or post-traumatic or rheumatoid osteoarthritis, avascular onecrosis fracture of the femoral head or fracture of the femoral neck, after a previous surgical intervention, after osteosynthesis, reconstruction of the joint,
  • Manufacturer
    manufacturer #121

Manufacturer

manufacturer #121
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA