TY  - JOUR
T1  - Monitoring the Introduction and Performance of a Joint Replacement: The United Kingdom Metal-on-Metal Alert
AU  - Tucker, Keith
AU  - Gregg, Paul
AU  - Kay, Peter
AU  - Porter, Martyn
AU  - Howard, Peter
AU  - Pickford, Martin
AU  - Cacou, Crina
Y1  - 2011/12/21
N1  - 10.2106/JBJS.K.01107
JO  - The Journal of Bone & Joint Surgery
SP  - 37
EP  - 42
VL  - 93
IS  - Supplement_3
N2  - 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.
SN  - 0021-9355
M3  - doi: 10.2106/JBJS.K.01107
UR  - http://dx.doi.org/10.2106/JBJS.K.01107
ER  -