LEGION 71434263Recalls & reported problems
Smith & Nephew, Inc. · LEGION CONSTRAINED INSERT TRIAL 13MM SIZE 7-8 · Class 1
All models of LEGION (446)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 03596010549617), received between Aug 23, 2023 and Aug 23, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Fracture1
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 23, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING TKA SURGERY WHILE DOING THE INSERTION OF THE LEGION CONSTRAINED SIZE 7-8 13MM TRIAL; BOTH POSTERIOR EDGES OF THE TRIAL HAD FRACTURE INSIDE THE PATIENT. THE SURGEON REMOVED THE BROKEN PIECES FROM THE PATIENT, WASHED THE AREA WITH SALINE AND SUCTIONED THE FLUID. THE AREA WAS RECHECKED FOR DEBRIS AND WITH THE AREA CLEAR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17608203 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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