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LEGION 71424025Recalls & reported problems

Smith & Nephew, Inc. · LEGION PRESSFIT STEM 12MM X 120MM · Class 2 · Implant

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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010546654), received between Feb 20, 2019 and Feb 20, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K072531, K230653); they may or may not involve this specific model.

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

  • Insufficient Device Problem Information1

Patient problems

  • Swelling1

Recent adverse event reports

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

  • InjuryFeb 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT PRESENTED SWELLING AND REDNESS IN THE RIGHT KNEE. THE CAUSE OF THE SWELLING AND REDNESS IS UNKNOWN. THE PATIENT WAS PRESCRIBED TO TAKE REST AND MEDICATION THERAPY.

    Patient problems: Swelling

    MAUDE report 8352790 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072531, K230653. One submission often covers many models, so check the product and lot details in each record.

  • Z-2621-2023 · Aug 31, 2023 · Open, Classified
    smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page