Events

Safety Alert for prosthesis for joint replacement

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Hoffmann S.R.L || Smith & Nephew Orthopaedics Ag || Aap Biomaterials Gmbh || Smith & Nephew, Inc || Straits Orthopaedics (Mfg) Sdn. Bhd || Medicalplastic.

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
    R1604-166
  • Event Number
    2014DM-0001903-R1
  • Date
    2016-04-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=145
  • 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 for joint replacement
  • Model / Serial
    Concerning the product R3 0 DEGREE XLPE ACETABULAR LINER 32MM ID X OD 48MM reference || 71339548, lot 15LM07776.
  • Product Description
    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
    Hoffmann S.R.L || Smith & Nephew Orthopaedics Ag || Aap Biomaterials Gmbh || Smith & Nephew, Inc || Straits Orthopaedics (Mfg) Sdn. Bhd || Medicalplastic

Manufacturer

Hoffmann S.R.L || Smith & Nephew Orthopaedics Ag || Aap Biomaterials Gmbh || Smith & Nephew, Inc ...
  • Source
    NIDFSINVIMA