MyKnee LBS 4.3613MRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030870293), received between Nov 22, 2017 and Nov 22, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionNov 22, 2017Material Deformation; Material Deformation

  THE SLOT OF THE MYKNEE FEMORAL CUTTING GUIDE WAS TOO TIGHT. EVEN THOUGH THE SURGEON USED A SAW BLADE OF A PROPER THICKNESS (1.27 MM), IT WAS ALMOST IMPOSSIBLE TO PERFORM THE FEMORAL DISTAL CUT. BECAUSE OF THE TIGHTNESS OF THE SLOT, THE MYKNEE CUTTING BLOCK PARTIALLY MELT AROUND THE SAW BLADE. THE SURGEON WAS FORCED TO FINISH THE DISTAL CUT USING THE CONVENTIONAL CUTTING BLOCK (THE METALLIC ONE), CAUSING A DELAY OF OPERATING TIME OF ABOUT 5 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7052122 ↗