LEGION 71434129Recalls & reported problems
Smith & Nephew, Inc. · LEGION TIBIAL BASE TRIALS TRAY · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010553492), received between Aug 4, 2025 and Aug 4, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Flaked” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Flaked1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2025Flaked; Peeled/Delaminated; Flaked; Peeled/Delaminated
IT WAS REPORTED THAT DURING THE SETUP FOR A TOTAL KNEE ARTHROPLASTY SURGERY, IT WAS NOTICED THAT THE INNER PLASTIC OF ONE LEGION TIB BASE TRIALS TRAY WAS PEELING AND CHIPPING OFF. THE PROCEDURE WAS PERFORMED, AFTER A SIGNIFICANT SURGICAL DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22710271 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.