Events

Recall of ADEPT 12/14 Modular Head (Used as femoral head component in metal on metal (MoM) total hip arthroplasty)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd T/A Depuy Australia.

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-2013-RN-00054-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-02-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00054-1
  • 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
    Review of post-market surveillance data suggests a higher than expected revision rate for the adept® 12/14 modular head used in conventional total hip arthroplasty (tha). in september 2012 the aoa njrr reported a cumulative revision rate of 7.1% (95% ci 3.6% to 13.6%) at 3 years with 8 revisions in a cohort of adept® cases (adept® cups used in conjunction with adept® 12/14 modular heads) used in conventional total hip arthroplasty. the identified reasons for the revisions are 4 loosening/lysis, 2 infections, 1 prosthesis dislocation and 1 pain. an analysis of uk njr data (download 11th november 2012) indicated a cumulative revision rate of 12.1% (95% ci 9.5% to 15.4%) at 7 years for the adept® 12/14 modular head when used in conventional total hip arthroplasty based on 109 revisions from 1582 recorded procedures. when this combination is used with the adept® cementless stem, the data showed a cumulative revision rate of 9.7% (95% ci 5.9% to 15.5%) at five years.
  • Action
    J&J; is advising implanting/treating surgeons on how to manage patients implanted with the Adept 12/14 Modular Head. For more information, please see http://www.tga.gov.au/safety/alerts-device-hip-ahm-130318.htm .

Device

ADEPT 12/14 Modular Head (Used as femoral head component in metal on metal (MoM) total hip arthro...

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia