title: Monitoring the introduction and performance of a joint replacement: the United Kingdom metal-on-metal alert.
abstract: Recent events have made us question our ability to monitor the introduction and performance of a new prosthetic joint replacement. These concerns are mirrored in many other countries, even those with joint registries and other systems for detecting poorly performing implants. In the United Kingdom, as is the case in most European Union countries, we have assessment processes in place, particularly the CE (Conformité Européenne) mark, the National Joint Registry, and the Orthopaedic Data Evaluation Panel. It is important to realize that these organizations can only react to poor performance; it is not within their power as monitoring agencies to prevent a poor implant from entering the market. When an implant has been shown to perform badly, it is referred to the Medicines and Healthcare products Regulatory Agency (MHRA), which then discusses the report with the manufacturer. When it is deemed that there is unequivocal evidence of a serious problem with the implant, the MHRA issues alerts to all hospitals and practitioners. We have continuing concerns about how to assess and monitor modifications to already existing devices. Suggestions are made for improvements to this system, and the authors will welcome feedback.
authors.affiliation: The Mill House, Mill Road Barnham Broom, Norwich, Norfolk NR9 4DE, United Kingdom. ktucker77@aol.com
authors.forename: Keith
authors.initials: K
authors.lastname: Tucker
authors.forename: Paul
authors.initials: P
authors.lastname: Gregg
authors.forename: Peter
authors.initials: P
authors.lastname: Kay
authors.forename: Martyn
authors.initials: M
authors.lastname: Porter
authors.forename: Peter
authors.initials: P
authors.lastname: Howard
authors.forename: Martin
authors.initials: M
authors.lastname: Pickford
authors.forename: Crina
authors.initials: C
authors.lastname: Cacou
mesh_terms: D019643:Arthroplasty, Replacement / Q000295:instrumentation*; D019644:Arthroplasty, Replacement, Hip / Q000295:instrumentation; D019985:Benchmarking / Q000706:statistics & numerical data*; D019544:Equipment Failure Analysis; D006622:Hip Prosthesis / Q000009:adverse effects; D006801:Humans; D007595:Joint Prosthesis / Q000009:adverse effects*; D008670:Metals / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D012042:Registries / Q000706:statistics & numerical data*; D006113:United Kingdom
chemical_list: D008670:Metals