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Monitoring the Introduction and Performance of a Joint Replacement: The United Kingdom Metal-on-Metal Alert
Keith Tucker, FRCS1; Paul Gregg, MD, FRCS2; Peter Kay, FRCS3; Martyn Porter, FRCS4; Peter Howard, FRCS5; Martin Pickford, PhD6; Crina Cacou, PhD7
1 The Mill House, Mill Road Barnham Broom, Norwich, Norfolk NR9 4DE, United Kingdom. E-mail address: ktucker77@aol.com
2 The Old Vicarage, Grinton, Swaledale, North Yorkshire DL11 6HR, United Kingdom
3 Stamford Lodge, 238 Ashley Road, Hale, Altringham, Cheshire WA15 9ND, United Kingdom
4 Holly House, Hare Lane Pipers Ash, Chester CH 7ED, United Kingdom
5 Seven Spouts Farmhouse, Ingleby Lane, Ticknall, Derby DE73 71Q, United Kingdom
6 Downland Close, Locks Heath, Southampton, Hampshire SO31 6WB, United Kingdom
7 Medicines and Healthcare Products Regulatory Agency, 151 Buckingham Palace Road, London SW1W 9SZ, United Kingdom
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Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. Also, one or more of the authors has had another relationship, or has engaged in another activity, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

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Investigation performed at the National Joint Registry of England and Wales

Copyright © 2011 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2011 Dec 21;93(Supplement 3):37-42. doi: 10.2106/JBJS.K.01107
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Abstract

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.

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    Accreditation Statement
    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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