My Knee Tibial Cutting Blocks 4.1032Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030848155), received between Nov 22, 2024 and Nov 22, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning 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 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.

• MalfunctionNov 22, 2024Positioning Problem; Positioning Problem

  DURING THE PRIMARY KNEE SURGERY, IT WAS OBSERVED THAT THE TIBIAL CUT BLOCK WOULD NOT SIT ON THE NATIVE BONE PROPERLY AND THAT THE ALIGNMENT WAS OFF. IN DETAIL, THE CUT BLOCK WOULD NOT FIT ON THE LATERAL SIDE OF THE TIBIA PROPERLY. WHEN THE SURGEON WOULD TRY TO PLACE ON THE MEDIAL OSTEOPHYTE IT WOULD KICK THE CUT BLOCK FORWARD AND MEDIAL AND THE ANTERIOR PAD WOULD NOT SIT FLUSH. THE BONE WAS PROPERLY CLEANED. TO COMPLETE THE CASE, THE SURGEON HAD TO HOLD THE BLOCK A CERTAIN WAY AND PIN IT. THERE WAS A 25- MINUTE DELAY BECAUSE OF THE ATTEMPTS TO GET THE CUT BLOCK TO FIT IN PLACE AND THE INTENTION TO USE AN IM GUIDE. THE SURGERY WAS ANYWAY COMPLETED SUCCESSFULLY. A CONSIGNMENT SET WAS UTILIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20755832 ↗