Legion 71935633Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556716212), received between Jun 7, 2024 and Sep 11, 2024 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2024Break; Crack; Fracture; Break; Crack; Fracture

  IT WAS REPORTED THAT DURING SURGERY, UNDER THE MODULAR DRIVING PLATFORM WHERE IT CONNECTS THERE IS A PIECE THAT BROKE OFF. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20191079 ↗
• MalfunctionSep 11, 2024Break; Break

  IT WAS REPORTED THAT DURING SURGERY, UNDER THE MODULAR DRIVING PLATFORM WHERE IT CONNECTS THERE IS A PIECE THAT BROKE OFF. IT IS UNKNOWN HOW THE PROCEDURE WAS RESUMED. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190928 ↗
• MalfunctionJun 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE BOTTOM OF TWO (2) MODULAR DRIVING PLATFORM BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19484814 ↗