Recall of the ASR XL Head and Hip Resurfacing Systems.

ABSTRACT

At the beginning of the 21st century, use of large-diameter, metal-on-metal devices was a popular procedure for hip replacement in young and physically active patients; however, within a few years, the number of revisions increased, resulting in a worldwide recall for the articular surface replacement (ASR) system. Complication rates for the ASR devices implanted at the authors' department are reported, with revision rates of 32% and 30% in the ASR XL Head and ASR Resurfacing groups, respectively. Reasons for revision surgery were serum metal ion elevation, luxation or subluxation, aseptic loosening, soft tissue compromise (adverse reactions to metal debris [ARMD]), and infection. The calculated implant survival for the ASR XL Head system and the ASR Resurfacing device (DePuy Orthopaedics Inc, Warsaw, Indiana) in the current series was 79% and 90%, respectively, at 60 months. Symptomatic patients with metal-on-metal devices, with or without elevated metal ion concentrations, should undergo cross sectional imaging to exclude ARMD. In cases of increased metal ion concentrations, local pain, or ARMD, revision surgery has to be evaluated. In the future, closer monitoring of new implants is needed to prevent high failure rates, as seen with the ASR design. Furthermore, the withdrawal of the device highlights the importance of national implant registries. [Orthopedics. 2017; 40(2)e340-e347.].