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LEGION 71423038Recalls & reported problems

Smith & Nephew, Inc. · SCR-ON HEM STP TIB WDG SZ 3-4 10MM LT-LA/RT-MD · 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010506368), received between Oct 29, 2021 and Oct 29, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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

  • Break1

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.

  • MalfunctionOct 29, 2021Break; Break

    IT WAS REPORTED THAT, DURING SET UP FOR A TKA SURGERY, THE BOX HAS A RATTLE THAT WAS NOT NORMAL. IT SOUNDED LIKE THE SC HM ST 3-4 10MM LTLA RTMD WAS BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED; HOWEVER, NO DELAY WAS REPORTED. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12722556 ↗

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

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