KneeAlign 2 133631Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00858704006008), received between Jun 30, 2017 and May 5, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE POD WAS NOT CORRESPONDENCE WITH THE SENSOR OF THE KNEEALIGN. THE READING ON THE SCREEN WAS SHOWN AS 13 DEGREE FLEXION, WITH SURGEON CHECKED ON THE RESECTION GUIDE AND IT'S NOT. THE ISSUE WAS COMPLETED WITH OPEN A NEW KNEEALIGN2 CONSUMABLE AND CHANGE OF THE KNEEALIGN SENSOR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14286500 ↗
• MalfunctionApr 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ALL CALIBRATION WAS DONE AND PASSED. KNEEALIGN POD HAS REGISTERED FEMUR OFFSET AND CENTRE OF HIP ROTATION PERFORMED BY SURGEON. SURGEON ADJUSTED FINAL ANGLE AS VARUS 1 DEGREE FOR FEMURCUTTING BLOCK TO SIT HOWEVER UPON REMOVING THE KNEEALIGN POD AND SENSOR, AN OBVIOUS VALGUS CUT WAS SHOWN WHEN THE SURGEON DOUBLE CHECK WITH A RESECTION GUIDE PRIOR SAWING THE FEMUR. SURGEON ABORT THE USAGE OF KNEEALIGN IN ASSISTING FOR FEMUR CUTS AND PROCEED ON USING CONVENTIONAL JIG INSTEAD. SURGEON THEN ATTEMPT TO USE KNEE-ALIGN AGAIN FOR TIBIAL CUTS, SAME OUTCOME AS ABOVE MENTIONED. SURGEON DECIDED TO PROCEED WITH CONVENTIONAL SAWING WITHOUT THE AID OF NAVIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681557 ↗
• InjuryJun 30, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE SURGEON DID MAKE HIS CUTS WITH THE UNIT. HE DID NOT AGREE WITH THE FEMORAL RESECTION (IT WAS A EXCESSIVE VALGUS ANGLE) AND HAD TO REVISE HIS CUT WITH THE TRADITIONAL RESECTION TOOLS.

  Patient problems: Joint Disorder

  MAUDE report 6682593 ↗