Events

Recall of Apex K2 Modular Hip Replacement System (total joint prosthesis)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Global Orthopaedic Technology 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-2012-RN-01012-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-10-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01012-1
  • 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 annual reports of the australian national joint registry [njrr], have indicated a higher than expected revision rate for this prosthesis since 2010. the 2011 njrr report indicated that the cumulative revision rate for the device was 5.2% at 1 year from the time of implantation, and a headline revision rate of 4.6 revisions per 100 observed years. the revision rate for the implant continues to be higher than that of similar implants being used in australia. the apex k2 stem has not been available for implantation since early october 2011.This device has now also been cancelled from the australian register of therapeutic goods as well as the private hospital prosthesis list.
  • Action
    Global Orthopaedic Technology is advising implanting/treating surgeons on how to manage patients implanted with Apex K2 Femoral Stem. For more details, please see http://www.tga.gov.au/safety/alerts-device-hip-apex-k2-121030.htm

Device

Apex K2 Modular Hip Replacement System (total joint prosthesis)
  • Model / Serial
    Apex K2 Modular Hip Replacement System (total joint prosthesis)Multiple Catalogue NumbersPrevious ARTG Number: 149020
  • Manufacturer
    Global Orthopaedic Technology Pty Ltd

Manufacturer

Global Orthopaedic Technology Pty Ltd