Events

Safety Alert for Full name: System for total femoral-tibial-patellar multi-compartment total arthroplasty ANVISA registration number: 80102511373 Hazard class: III Affected model: Ceramic alumina heads 36 mm Series numbers affected: 0211313520; 0311327277; 0311337209; 1555038; 1648756; 1650634; 1633531; 1648754; 1602583; 1655960; 1668359; 1655972; 1655960; 1648759; 1655972; 15541511687588; 15546491621617; 14519031660611; 1555037; 1684826; 1633530; 1656049; 0656748101; 016316886; 065: 05810312; 085: 05810102; 0557332101; 0657633801; 0556748101; 1648801.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; MICROPORT ORTHOPEDICS INC..

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
    2211
  • Date
    2017-03-06
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    Product purchasers should immediately: evaluate their inventory and segregate related parts for product return, which will be forwarded to the manufacturer. Conduct to be taken in cases where the implant has already been implanted: MicroPort Orthopedics recommends that surgeons maintain their protocol and the standard follow-up measures in their patients and ensure that patients are informed of the symptoms (in particular, pain, instability, difficulty walking and / or performing common tasks) that indicate the need for revision surgery. Any adverse events or doubts should be reported to the registry holder in Brazil via email or telephone so that the manufacturer is activated and the health authorities are also informed.
  • Reason
    The action voluntary retrieval of biolox forte 36mm alumina ceramic heads belonging to the record 80102511373 was started because the implants will be updated with a label indicating the numeric offset of the ceramic head instead of the label currently used which indicates (short, medium, long ), because during a microport investigation the biolox forte 36 mm alumina ceramic head was confirmed to be about 2 mm smaller than other microport 36 mm femoral heads (cobalt chrome and biolox delta femoral heads).
  • Action
    Field Action Code AC0317 triggered under the responsibility of the company VR MEDICAL IMPORTADORA AND DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA. Company will collect.

Device

Full name: System for total femoral-tibial-patellar multi-compartment total arthroplasty ANVISA r...

Manufacturer

VR MEDICAL IMPORTADORA E DISTRIBUIDORA DE PRODUTOS MÉDICOS LTDA; MICROPORT ORTHOPEDICS INC.
  • Source
    ANVSANVISA