Journal of Bone & Joint Surgery, Vol 93. Supplement 3-Multiple Articles

Journal Journal of Bone & Joint Surgery, Vol 93. Supplement 3 – International Consortium of Orthopedic Registries
Authors Multiple
Year Published 2011
Link to Publication

 List of 14 Articles

  • The International Consortium of Orthopaedic Registries: Overview and Summary
  • A Scandinavian Experience of Register Collaboration: The Nordic Arthroplasty Register Association (NARA)
  • Comparison of the Norwegian Knee Arthroplasty Register and a United States Arthroplasty Registry
  • Comparison of Community-Based ACL Reconstruction Registries in the U.S. and Norway
  • Monitoring the Introduction and Performance of a Joint Replacement: The United Kingdom Metal-on-Metal Alert
  • A Multinational Assessment of Metal-on-Metal Bearings in Hip Replacement
  • The Role of Registry Data in the Evaluation of Mobile-Bearing Total Knee Arthroplasty
  • What Is the Benefit of Introducing New Hip and Knee Prostheses?
  • Impact of Implant Developers on Published Outcome and Reproducibility of Cohort-Based Clinical Studies in Arthroplasty
  • RSA and Registries: The Quest for Phased Introduction of New Implants
  • Use of Patient-Reported Outcomes in the Context of Different Levels of Data*
  • Challenges in Prosthesis Classification
  • Stages and Tools for Multinational Collaboration: The Perspective from the Coordinating Center of the International Consortium of Orthopaedic Registries (ICOR)
  • Outlier Analysis in Orthopaedics: Use of CUSUM:Â The Scottish Arthroplasty Project: Shouldering the Burden of Improvement

The International Consortium of Orthopaedic Registries: Overview and Summary

Journal The Journal of Bone and Joint Surgery
Authors Sedrakyan, Art; Paxton, Elizabeth; Phillips, Charlotte; Namba, Robert; Funahashi, Tadashi; Barber, Thomas; Sculco, Thomas; Padgett, Douglas; Wright, Timothy; Marinac-Dabic, Danica
Year Published 2011
Link to publication

The United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) monitors both mandatory and voluntary post-market reporting to identify adverse events and problems associated with medical devices. Although the manufacturers of medical devices are required to report deaths, injuries, and malfunctions directly to the FDA, the device users are required to report these events to the manufacturer and are required to report only deaths to the FDA. Voluntary reporting systems such as the MedWatch program, the MAUDE (Manufacturer and User Facility Device Experience) database, and the MedSun (Medical Product Safety Network) enhanced surveillance network2,3 provide nationwide medical device surveillance in the U.S. However, these reporting systems have important weaknesses, such as incomplete, inaccurate, or nonvalidated data, reporting biases related to event severity, concerns that reporting may result in adverse publicity or litigation, and general underreporting of events. Most importantly, denominator data are missing, which makes evaluation of the incidence or prevalence of a safety-related event impossible.