Failure Modes of Total Wrist Arthroplasty: Cross-Sectional Analysis of FDA MAUDE Adverse Event Reports (2015-2025)
Hand · 13 Aug 2026
† Impact is the editorial-priority score. All scores are out of 100. Clinical is a stored clinical-importance score from the earlier method; it has not been recalculated.
Why it matters
For hand surgeons counselling patients about TWA durability, this catalogs the real-world complication landscape (loosening, instability, infection) that persists despite implant design advances, reinforcing that TWA should be reserved for carefully selected, lower-demand patients.
The evidence
This is a cross-sectional review of the FDA MAUDE database looking at adverse event reports for total wrist arthroplasty (TWA) from 2015-2025. Among 313 classifiable reports, aseptic loosening/component migration was the most common failure mode (36.7%), followed by dislocation/instability (18.2%) and infection (13.1%); Stryker and Zimmer Biomet accounted for the vast majority (81.6%) of manufacturer-attributed reports. Because MAUDE lacks denominator data, the authors could only describe patterns of reported complications, not true incidence or comparative failure rates.
A coherent primary effect estimate is unavailable. Clinical relevance does not estimate treatment benefit.
Why this rigour score?
Retrospective cohort
Methods at a glance
Recorded assessment- Confounding adjustmentNot applicable
- Covariate balance confirmedNot applicable
- Outcome assessors blindedNot applicable
- Comparable start of follow-upNot applicable
- Adequate statistical powerNot applicable
- Prospective registrationNot applicable
Not reported does not mean not done. Checks have different weights; this is not a count of boxes ticked.
How to read this assessment
The recorded methods are shown alongside the published score. A verified point-by-point calculation is not available for this version of the appraisal.
Checklist from the stored appraisal. “Not met” describes the recorded criterion; it does not always produce a deduction. This overview supports reading the full study.
For journal club
1.Given that loosening and instability remain the dominant failure modes across implant generations and manufacturers, how should patient selection criteria for TWA be refined beyond simply 'low-demand' status?
2.When TWA fails due to loosening or infection, how should surgeons counsel patients preoperatively about the tradeoffs between salvage arthrodesis (loss of motion) versus revision arthroplasty?
Original publication title
Failure Modes of Total Wrist Arthroplasty: Cross-Sectional Analysis of FDA MAUDE Adverse Event Reports (2015-2025)