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LEGION 71434542Recalls & reported problems

Smith & Nephew, Inc. · LEGION HINGE GUIDED MOTION TIBIAL INSERT TRIAL 11MM SIZE 4-5 RIGHT · Class 1

All models of LEGION (446)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556259009), received between Jul 15, 2019 and Jul 15, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Connection Problem” (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 18, 2026.

Most reported problems

Device problems

  • Connection Problem1

Patient problems

  • Injury1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 15, 2019Connection Problem; Connection Problem

    IT WAS REPORTED THAT DURING SURGERY THE SURGEON BELIEVED THE TRIAL COMPONENT PARTS WERE ADEQUATELY LOCKED TOGETHER DURING A TRIAL REDUCTION. LATER DETERMINED THEY WERE NOT, RESULTING IN THE NEED FOR 5MM FEMORAL AUGMENTS. FINAL POLY INSERT IMPLANT WAS ALSO EXCHANGED FOR A LARGER SIZE. LESS THAN 30 MINUTES DELAY WAS REPORTED AND A BACKUP DEVICE WAS AVAILABLE.

    Patient problems: Injury

    MAUDE report 8791759 ↗

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Sources and updates

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