A Cross-sectional Analysis of the Femoral Neck System From Medical Device Reports: A National Database Study.

The Femoral Neck System (FNS) offers high resistance against angular instability and femoral head rotation by simultaneously remaining minimally invasive. This study reports the complication profile of FNS in real-time to assess the risk-benefit of this device. The Manufacturer and User Facility Device Experience (MAUDE) nationwide database was used to identify complications related to the FNS between January 1, 2018 and January 1, 2022. Data collected included the date the reports were received by the FDA, the type of complication, event description, and the source of report. Of the 182 complication entries reported, 67.5% of the complications were related to the FNS, and 94.5% were classified as an injury. The most common reported type of complication was peri-implant fracture (25.8%; 47 entries), of which, 36 entries were specified as subtrochanteric fracture. This study suggests that the FNS offers excellent construct stability; however, potential stress risers in the subtrochanteric region can be formed and predispose patients to peri-implant fractures. (Journal of Surgical Orthopaedic Advances 34(4):178-181, 2025).