New warnings about the Apex K2 modular femoral stem were contained in the newly-released Australian National Joint Replacement Registry report. This report is published annually by the Australian Orthopaedic Association.
The 2016 edition of the report, published this month, said:
This year the Registry identified the Apex stem in combination with five acetabular components in Stage 1. As per our approach to identifying prostheses with higher than anticipated revision, an additional analysis was performed on the individual stem.There were 106 revisions from 2,204 reported cases and the cumulative percent revision at 10 years was 8.6%. There were 81 major revisions and the Apex stem was combined with 30 different acetabular components.There were 24 revisions for loosening/lysis, 25 for dislocation and 17 for infection. There were revisions in all five states and territories that used the device.
The Australian regulatory body TGA announced in 2012 that the Apex K2 implant would no longer be sold in Australia because of higher than expected revision rates.