Reporting and Notification of Adverse Events in Orthopaedics

J Am Acad Orthop Surg, Vol 18, No 4, April 2010 William M. Mihalko, MD, PhD, A. Seth Greenwald, D Phil (Oxon), Jack Lemons, PhD and John Kirkpatrick, MD, MS

Surgeons should know how to alert the US FDA when an adverse event occurs with a device that has been approved by the FDA. Documentation of such events is critically important to help identify trends concerning a particular device, thereby helping surgeons and other health care professionals avoid similar events. The FDA created the MedWatch program to aid health care professionals in reporting adverse events. Orthopaedic surgeons can use the program to get up-to-date alerts and help protect their patients.