Events

Recall of MSA Hip SystemMSA Neutral Femoral Neck

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Global Manufacturing 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-2014-RN-00685-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00685-1
  • 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 2013 annual report of the national joint replacement registry (njrr) indicates that up to december 2012, the cumulative percent revision of the msa hip system has been calculated as 6.2 % at one year and approximately 11% at 2 years , both of which are significantly higher than that of other hip replacement prostheses. the most common reasons for revision of msa to date have been loosening/lysis and peri-prosthetic fracture, but there have also been a few revisions due to prosthesis dislocation, pain and infection.After consultation with the therapeutic goods administration, a decision has been made by global orthopaedic technology to cease supply of the msa hip stem. this device has been removed from the australian register of therapeutic goods.
  • Action
    Global Orthopaedic Technology is informing implanting surgeons that it is advisable for annual clinical and radiological examinations to be performed on patients who have been implanted with this device, in accordance with routine patient post arthroplasty care. For more details, please see http://tga.gov.au/safety/alerts-device-msa-hip-system-140703.htm .

Device

MSA Hip SystemMSA Neutral Femoral Neck
  • Model / Serial
    MSA Hip SystemMSA Neutral Femoral Neck Catalogue number range: GH-220-00 to GH-260-08MSA Ante-Retro-Version Femoral Neck Catalogue number range: GH-221-00 to GH-261-00MSA Titanium HA Custom Femoral Stem Catalogue number range: GH-1400-00 to GH-14000-25ARTG Number: 120787
  • Manufacturer
    Global Manufacturing Technology Pty Ltd

Manufacturer

Global Manufacturing Technology Pty Ltd