How Often Does Technology Fail in Robotic-Assisted Arthroplasty? A Comprehensive Analysis of a United States Food and Drug Administration Database

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BackgroundRobotic-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. MethodsThe 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. The AEs were calculated using national surgical numbers provided by the manufacturer and grouped by total hip arthroplasty (THA), total knee arthroplasty (TKA), or partial knee arthroplasty (PKA). ResultsThere were 1,710 unique AEs across the study period, with 436 THA, 1,005 TKA, and 269 PKA, representing incidence rates of 0.37, 0.30, and 0.40%, respectively. All procedures demonstrated lower rates of AEs in the final year of the study, compared to the first year. Most complications were related to mechanical problems, not software issues. Surgical delays due to AEs occurred in THA (0.13% cumulative incidence, 14.0 minutes average delay), TKA (0.13%, 20.6 minutes), and PKA (0.22%, 19.4 minutes). No cases were canceled due to AEs in THA, though a few TKA (0.003%) and PKA (0.02%) cases were not performed. Patient injuries occurred in 0.05, 0.05, and 0.08% of THA, TKA, and PKA, respectively. Surgical reintervention was necessary in 0.004, 0.003, and 0.01% of THA, TKA, and PKA, respectively. ConclusionsRobotic-assisted arthroplasty has a small number and relatively low rate of AEs reported to the FDA as measured through the Manufacturer and User Facility Device Experience database, with rates steadily decreasing over the study period. Patient injury, case delay, and reoperation represent only a small fraction of the already rare AEs in the database.