LEGION 71423097Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010546425), received between Feb 23, 2021 and Feb 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fitting 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 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionFeb 23, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, SURGEONS WEREN'T ABLE TO TIGHTEN THE TIBIAL WEDGE SCREW IN TO THE WEDGE, SO A SPARE SCREW WAS USED TO REPLACE THE FAILED ONE (BACKUP DEVICE). INSTRUMENTS WERE OUTSIDE THE PATIENT. THERE WAS NO DELAY OR FURTHER COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366330 ↗