Chapter 29

Orthopedic Devices: Epidemiologic Considerations

Ronald G. Kaczmarek MD, MPH

Ronald G. Kaczmarek MD, MPH

Medical Officer

Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, HFZ-541, Rockville, MD 20850, USA

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Michele G. Bonhomme PhD

Michele G. Bonhomme PhD

Epidemiologist

Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, HFZ-541, Rockville, MD 20850, USA

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Stanley A. Brown PhD

Stanley A. Brown PhD

Research Biomedical Engineer

Division of Solid and Fluid Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, 12720 Twinbrook Parkway, HFZ-150, Rockville, MD 20857, USA

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Judith U. Cope MD, MPH

Judith U. Cope MD, MPH

Epidemiologist

Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, HFZ-541, Rockville, MD 20850, USA

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Daniel S. McGunagle

Daniel S. McGunagle

Chemist

Product Evaluation Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, HFZ-520, Rockville, MD 20850, USA

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First published: 02 March 2007

Summary

This chapter contains sections titled:

  • Introduction

  • Selected orthopedic materials

  • Artificial hips

  • Intervertebral disc replacement

  • Data sources and selected methodological issues to consider in epidemiologic

  • studies of orthopedic medical devices

  • Summary

  • References

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