Events

Recall of seleXys TH+ and seleXys TPS acetabular shells (acetabular component for the joint hip prosthesis)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Mathys Orthopaedics 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-00770-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-09-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00770-1
  • 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
    Mathys orthopaedics pty. ltd. is issuing this hazard alert for its selexys th+ and tps acetabular shells used in total hip arthroplasty due to higher than expected revision rates. a detailed analysis of the aoa njrr data in april 2015 showed that the individual revision rate of selexys tps acetabular shells was 1.79 revisions per 100 component years and the revision rate of selexys th+ acetabular shells was 4.28 revisions per 100 component years. the analysis of the registry data identified a higher than expected rate of revision due to early loosening/lysis with the selexys th+ and selexys tps acetabular shell.
  • Action
    Mathys ceased supply of seleXys TH+ and seleXys TPS acetabular shells in Australia in April 2013 and June 2014, respectively. Mathys is recommending that surgeons maintain their routine follow-up protocol for patients who have undergone hip arthroplasty. The majority of additional revisions have been due to loosening/lysis, bone fracture, dislocation and pain. You may wish to consider more frequent or additional follow-up, but revision surgery should be determined on a case-by-case basis following a detailed assessment of the patients’ clinical circumstances. For further information, please see https://www.tga.gov.au/alert/selexys-th-and-tps-acetabular-shells-used-hip-replacements . This action has been closed-out on 20/06/2016.

Device

seleXys TH+ and seleXys TPS acetabular shells (acetabular component for the joint hip prosthesis)
  • Model / Serial
    seleXys TH+ and seleXys TPS acetabular shells (acetabular component for the joint hip prosthesis)seleXys TH+ Catalogue number range: 55.42.0142 - 55.42.0164seleXys TPS Catalogue number range:: 55.40.0042 - 55.40.0064ARTG number: 122258
  • Manufacturer
    Mathys Orthopaedics Pty Ltd

Manufacturer

Mathys Orthopaedics Pty Ltd