Events

Safety Alert for Prosthesis System for Articular Replacements

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by manufacturer #121.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1510-479
  • Event Number
    2012DM-0009024
  • Date
    2015-10-28
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=169
  • Notes / Alerts
    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.
  • Extra notes in the data

Device

Prosthesis System for Articular Replacements
  • Model / Serial
    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.
  • Product Description
    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
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “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