Events

Recall of Vaios Total Shoulder Replacement System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Orthotech Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00976-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-10-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00976-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The tga has cancelled the vaios total shoulder replacement system, sponsored by orthotech, from the australian register of therapeutic goods (artg) due to a higher than expected revision rate. information published by the australian orthopaedic association’s national joint replacement registry (aoanjrr) indicated that the vaios total shoulder replacement system had a revision rate at two years of 17.6%. the comparable revision rate for all other total conventional shoulder implants was 5.5% at two years. the main reasons for revision were instability/dislocation, rotator cuff insufficiency and loosening/lysis.
  • Action
    Orthotech are advising clinicians to consider contacting patients who have been implanted with these devices to inform them of this issue. Implanting surgeons are advised to maintain their routine follow-up protocol for patients who have undergone shoulder arthroplasty. The need for any additional follow-up or revision surgery should be determined on a case-by-case basis following a detailed assessment of the patient’s clinical circumstances. This action has been closed-out on 29/08/2016.

Device

Vaios Total Shoulder Replacement System
  • Model / Serial
    Vaios Total Shoulder Replacement SystemARTG Number: 173236
  • Manufacturer
    Orthotech Pty Ltd

Manufacturer

Orthotech Pty Ltd