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

Recall

RC-2013-RN-00054-1

Class II

2013-02-25

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00054-1

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.

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 .