Failure Modes of Total Wrist Arthroplasty: Cross-Sectional Analysis of FDA MAUDE Adverse Event Reports (2015-2025).

BACKGROUND

Total wrist arthroplasty (TWA) is a motion-preserving alternative to wrist fusion for end-stage wrist arthritis, but concerns regarding long-term durability continue to limit broader use. Reported 10-year survivorship ranges from 70% to 80%, although real-world failure patterns remain poorly defined.

METHODS

Adverse events were reviewed for TWA devices submitted to the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database from January 1, 2015, to September 30, 2025. Reports were identified using the wrist arthroplasty device code and confirmed by manufacturer and implant name. Nonwrist devices and duplicate submissions were excluded. Event narratives were manually reviewed and assigned a primary failure mode using a predefined taxonomy. Reports lacking sufficient detail were excluded from analyses.

RESULTS

Among 313 unique reports with adequate information, loosening or component migration was the most common failure mode (37%), followed by dislocation or instability (18%) and infection (13%). Less common complications included tendon or nerve injury, polyethylene wear or metallosis, implant fracture, and periprosthetic fracture. Annual failure-mode reports peaked in 2022, with additional clustering in 2018 and 2019. Loosening/migration was most frequent in 2022, whereas dislocation/instability clustered in 2019. Manufacturer-year reporting was mostly by Stryker and Zimmer Biomet, though reports involved all manufacturer groups.

CONCLUSIONS

These findings describe submitted adverse events rather than true failure rates and reflect the limitations of passive reporting. Contemporary TWA continues to encounter substantial mechanical and fixation-related complications, highlighting the need for improved implant design, refined technique, and stronger post-market surveillance.