title: 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.].
authors.forename: Werner
authors.initials: W
authors.lastname: Maurer-Ertl
authors.forename: Joerg
authors.initials: J
authors.lastname: Friesenbichler
authors.forename: Lukas A
authors.initials: LA
authors.lastname: Holzer
authors.forename: Lukas
authors.initials: L
authors.lastname: Leitner
authors.forename: Kathrin
authors.initials: K
authors.lastname: Ogris
authors.forename: Michael
authors.initials: M
authors.lastname: Maier
authors.forename: Andreas
authors.initials: A
authors.lastname: Leithner
mesh_terms: D000328:Adult; D000368:Aged; D019644:Arthroplasty, Replacement, Hip / Q000295:instrumentation* / Q000706:statistics & numerical data; D005260:Female; D005500:Follow-Up Studies; D006622:Hip Prosthesis / Q000009:adverse effects*; D006801:Humans; D008297:Male; D057052:Medical Device Recalls; D061825:Metal-on-Metal Joint Prostheses / Q000009:adverse effects*; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011474:Prosthesis Design; D011475:Prosthesis Failure; D016459:Prosthesis-Related Infections / Q000175:diagnosis / Q000453:epidemiology / Q000601:surgery; D012086:Reoperation / Q000706:statistics & numerical data*; D012189:Retrospective Studies