Events

Recall of E.T.O.I.L.E sytem extension table (leg holder)(used in total hip arthroplasty)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Amplitude Australia 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-2016-RN-01625-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01625-1
  • 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
    Following a customer complaint about the e.To.I.L.E extension table, an analysis of the device showed a failure due to an abnormal wear in the locking system of the external rotation. a failure of the rotation locking mechanism would mean that the rotation of the leg would not be able to be maintained and may have the following consequences:- an increase in the surgery timeline if the incident occurs at the beginning of the surgery.- a risk of injury for the patient if the incident occurs during surgery.There have been no reported patient injuries. as a precautionary measure, amplitude decided to set up a preventive maintenance on all the e.T.O.I.L.E systems on the market.
  • Action
    Amplitude is arranging for the return of all devices for preventative maintenance. Replacement devices will be provided as necessary.

Device

E.T.O.I.L.E sytem extension table (leg holder)(used in total hip arthroplasty)
  • Model / Serial
    E.T.O.I.L.E sytem extension table (leg holder)(used in total hip arthroplasty)Reference: 3-0499902Serial Numbers: 1500044, E1210021, E1210022, E1210023ARTG Number: 216762
  • Manufacturer
    Amplitude Australia Pty Ltd

Manufacturer

Amplitude Australia Pty Ltd