NovoKnee Total Knee System 3311-4012Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00811382036538), received between Feb 20, 2025 and Feb 20, 2025 — 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 18, 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 20, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGERY A UC TIBIAL INSERT TRIAL SIZE 2 (3311-4012) WAS INSERTED, THE SURGEON PUT THE PATIENT KNEE THROUGH A RANGE OF MOTION, AND UPON REMOVAL THE UC TIBIAL INSERT TRIAL SIZE 2 (3311-4012) FRACTURED. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY OR DEATH, THAT THE SURGERY WAS NOT PROLONGED AND FINALLY THAT THE DEVICE WAS USED AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21424051 ↗