KneeAlign 2 402042Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00858704006336), received between Jul 3, 2019 and Sep 23, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873810 ↗
• MalfunctionJan 8, 2025Product Quality Problem; Product Quality Problem

  A SMALL BURR WAS FOUND ON THE SHAFT OF A NEW MICROBLOCK. ANOTHER MICROBLOCK OF THE SAME LOT WAS CHECKED AND IT ALSO HAD A BURR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103132 ↗
• MalfunctionSep 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MICROBLOCK IS LOOSE AND DROPS DOWN DURING USE. THE SURGEON IS UNCERTAIN WHERE TO MEASURE. THERE WAS NO IMPACT TO PATIENT AND THE CASE WAS COMPLETED WITH THE MICROBLOCK AND THE REST OF THE ORTHALIGN NAVIGATION SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279618 ↗
• InjuryJul 9, 2024Mechanical Problem; Mechanical Problem

  THE SURGEON REPORTED THAT THE TREADED PIN INTERFERED WITH THE PIN HOLE OF THE MICRBLOCK AND JAMMED IN THE PIN HOLE DUE TO PIN ECCENTRICITY DURING DRILLING.

  Patient problems: Metal Related Pathology; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702151 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED WITH KNEEALIGN. FEMORAL DISTAL CUT WAS SUPPOSED TO BE 9MM BUT THE FEMORAL BONE WAS ACTUALLY CUT ABOUT 15MM.

  Patient problems: Joint Laxity

  MAUDE report 12099232 ↗
• MalfunctionJul 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE'S TOO MUCH "PLAY" BETWEEN THE CUTTING GUIDE AND THE MICROBLOCK. ADDITIONAL INFORMATION PROVIDED INDICATED THAT THE SURGEON IS QUESTIONING ITS ACCURACY.

  Patient problems: Not Applicable

  MAUDE report 8759818 ↗