Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00054-1
Product Name/Description ADEPT 12/14 Modular Head (Used as femoral head component in metal on metal (MoM) total hip arthroplasty)

All product codes

All lots are affected

ARTG Number: 115691
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 25/02/2013
Responsible Entity Johnson & Johnson Medical Pty Ltd T/A Depuy Australia
Reason/Issue 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.
Recall Action Hazard Alert
Recall Action Instructions 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 .
Contact Information 02 9815 3661 - Johnson & Johnson Medical