By Michael E. Trice, MD, with the AAOS Biological Implants Committee
Although the U.S. Food and Drug Administration (FDA) has established policies and procedures to ensure the safety and effectiveness of medical devices before they are marketed in the United States, some devices that make it to the marketplace are subsequently found to be unsafe or ineffective. Hence the need for adverse event reporting.
Orthopaedic biologic implants, which are rapidly entering the marketplace, may pose special challenges for both the FDA and clinicians, underscoring the need for early physician reporting of adverse events in biological-based treatments. This article covers the need for and importance of adverse event reporting, as well as the steps that should be taken if an adverse event is suspected.