title: Reporting and notification of adverse events in orthopaedics.
abstract: 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.
authors.affiliation: Campbell Clinic Orthopaedics, Collierville, TN, USA.
authors.forename: William M
authors.initials: WM
authors.lastname: Mihalko
authors.forename: A Seth
authors.initials: AS
authors.lastname: Greenwald
authors.forename: Jack
authors.initials: J
authors.lastname: Lemons
authors.forename: John
authors.initials: J
authors.lastname: Kirkpatrick
mesh_terms: D016208:Databases, Factual; D004868:Equipment Failure; D004869:Equipment Safety; D006801:Humans; D019300:Medical Errors; D019637:Orthopedic Procedures / Q000009:adverse effects*; D011183:Postoperative Complications; D011358:Product Surveillance, Postmarketing; D011785:Quality Assurance, Health Care; D014481:United States; D014486:United States Food and Drug Administration