Background: Robotic-assisted arthroplasty is a growing alternative to conventionally instrumented arthroplasty; however, the incidence of adverse events (AEs) associated with this technology reported to the United States Food and Drug Administration (FDA) remains poorly quantified. The objective of this study was to categorize AEs associated with robotic-assisted arthroplasty and calculate their annual incidence as reported to the FDA.
Methods: The FDA's Manufacturer and User Facility Device Experience database was queried for AEs from January 1, 2017 to December 31, 2021 associated with the most prevalent robotic-arthroplasty system.