LEGION 71434262Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010549600), received between Jan 5, 2022 and Mar 11, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2022Break; Break

  IT WAS REPORTED THAT THE LEGION CON INS TRL 11MM SZ 7-8 WAS CHIPPED. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13735899 ↗
• MalfunctionJan 5, 2022Break; Break

  IT WAS REPORTED THAT, DURING A REVISION KNEE REPLACEMENT, WHILE THE TRIAL INSERT WAS BEING INSERTED, THE SURGEON HAD DIFFICULTY, THE INSERT WAS REMOVED AND THE SURGEON NOTICED DEBRIS ON THE TRIAL TIBIAL TRAY, THE TRIAL INSERT WAS CHECKED AND THE SURGEON NOTICED THAT A SMALL FRAGMENT WAS BROKEN. PROCEDURE WAS COMPLETED WITH SAME DEVICE WITH A DELAY LESS THAN OR EQUAL TO 30MIN. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172239 ↗