| 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 |
|
| 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 http://www.tga.gov.au/safety/alerts-device-hip-ahm-130318.htm . |
| Contact Information |
02 9815 3661 - Johnson & Johnson Medical |