Knee Instruments 02.12.10.0103Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040778800), received between Sep 8, 2020 and Sep 8, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjurySep 8, 2020Difficult to Remove

  DURING THE PRIMARY KNEE SURGERY, THE SURGEON HAD DIFFICULTIES TO REMOVE THE TRIAL INSERT. AS THE SURGEON TIRED TO MOVE THE TRIAL POLY, THE PATIENT SUSTAINED AN MCL SPRAIN. THE SURGEON HAD TO GIVE THE PATIENT A HINGE KNEE BRACE AS A RESULT OF THE SPRAIN. THERE WAS NO DELAY IN THE CASE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Sprain

  MAUDE report 10502559 ↗