Analysis of Adverse Events Associated with Total Knee Arthroplasty Using the FDA MAUDE Database

Total knee arthroplasty (TKA) is one of the most commonly performed orthopedic procedures for treating end-stage osteoarthritis. Although the procedure generally improves pain and mobility, adverse events may occur and can negatively affect patient outcomes while increasing healthcare costs. This study investigated adverse events associated with TKA prosthetic devices using data from the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. Reports associated with FDA product code OOG were collected for the years 2016 through 2025 and analyzed to identify trends in overall adverse events, injury reports, and malfunction reports. Annual case counts were compiled and visualized using line graphs. Results showed that reported adverse events generally increased over the study period, with total reports peaking in 2024. Injury reports demonstrated the largest increase, rising from 11 cases in 2023 to 64 cases in 2024, while malfunction reports fluctuated throughout the study period and remained comparatively lower. Although the MAUDE database cannot be used to determine true complication rates because of limitations such as underreporting and incomplete reports, it provides valuable information for identifying trends in post-market device performance. Continued surveillance of TKA adverse events may help improve prosthetic design, guide regulatory oversight, and ultimately enhance patient safety and clinical outcomes.