KneeAlign 2 133632Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00858704006015), received between May 14, 2019 and Feb 2, 2026 — classified as 8 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (15 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED, THE SURGEON QUESTIONED VARUS/VALGUS ACCURACY OF FEMORAL CUT. REPORTER WAS IN THE CASE AND EVERYTHING WENT AS IT SHOULD. THE SURGEON REDID THE MOVE THREE TIMES AND KEPT GETTING THE SAME RESULT AND HE FELT THE 0.0 WAS CUTTING VALGUS INTO THE CUT. HE THEN WENT TO 1.0 VARUS TO PLAY ON THE SAFE SIDE AND PROCEEDED TO CUT THE FEMUR AND STILL FELT IT WAS CUTTING VALGUS INTO THE FEMUR. THE CASE ENDED UP GOOD HOWEVER HE DIDN'T LIKE THE FEMORAL CUT AND WAS QUESTIONING THE ACCURACY. SURGEON'S OTHER TWO CASES TODAY HAD NO ISSUES. [THE SURGEON] DID NOT GO AND MAKE A REVISION CUT HE CONTINUED WITH THE PROCEDURE AND MADE UP FOR THE VALGUS IN OTHER AREAS.

  Patient problems: Joint Laxity

  MAUDE report 24241763 ↗
• MalfunctionDec 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE SENSOR FAILED AND THE DOCTOR STATED THE SENSOR HE WAS USING WAS INACCURATE BY A FEW DEGREES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23839168 ↗
• MalfunctionJun 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE SURGEON WAS ABLE TO REGISTER THE CENTER OF THE FEMORAL HEAD, BUT WHEN HE POSITIONED THE DEEP FLEXION AND LIFTED THE AFFECTED SIDE TO FIT THE BLACK BALL IN THE BOX AGAIN, IT WAS MARKED 20° OF FLEXION, AND HE HAD TO MAKE MAXIMUM ADJUSTMENTS WITH A SCREWDRIVER TO TRY TO MATCH 3° OF FLEXION. AS A RESULT, THE PADDLE COULD NOT BE ATTACHED TO THE GUIDE ROD, AND ACCURATE DISTAL FEMORAL OSTEOTOMY WAS NOT POSSIBLE. HE TRIED THE TIBIA AS IT WAS, AND THE TIBIA COULD BE OSTEOTOMIZED WITHOUT ANY PROBLEMS. THE SURGEON WAS UNABLE TO SET THE DISTAL FEMORAL OSTEOTOMY VOLUME SO THE CUT BLOCK WAS MOVED AND RE-PINNED MULTIPLE TIMES. THIS MAY HAVE AFFECTED THE FLEXION-EXTENSION AND INTERNAL/EXTERNAL ROTATION OF THE CUT BLOCK. THE SURGEON COMPLETED THE SURGERY WITH CONVENTIONAL INSTRUMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22133931 ↗
• MalfunctionMar 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  SURGEON BELIEVES CALIBRATION WAS INACCURATE. BLAMING AGE OF THE REFERENCE SENSOR. CONVENTIONAL INSTRUMENTS WERE USED TO COMPLETE THE PROEDURE AND MAKE THE DISTAL FEMUR AND TIBIA CUTS. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573573 ↗
• MalfunctionMar 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  SURGEON BELIEVES CALIBRATION WAS INACCURATE. BLAMING AGE OF THE REFERENCE SENSOR. CONVENTIONAL INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE AND MAKE THE DISTAL FEMUR AND TIBIA CUTS. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573547 ↗
• MalfunctionDec 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DURING PROCEDURE NAVIGATION UNIT MADE A LONG BEEPING SOUND AND SIGNALED TO CHANGE BATTERY IN THE REFERENCE SENSOR. AFTER THAT THE CUTS MAY HAVE BEEN OFF. PROCEDURE COMPLETED WITH TRADITIONAL INSTRUMENTATION.

  Patient problems: Intraoperative Cardiac Valve Injury

  MAUDE report 20832908 ↗
• MalfunctionOct 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DEVICE WAS SHOWING AN OSTEOTOMY OF ABOUT 14MM, BUT WHEN THE SURGEON CONFIMED WITH MANULA INSTRUMENTS HE FOUND THE OSTOTOMY TO BE 9MM. THE SURGEON CHANGED THE PINNING POSITION AND COMPLETED THE PROCEDURE. NO ADVERSE EVENT OR PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20397225 ↗
• MalfunctionJul 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  SURGEON BELIEVES CALIBRATION WAS INACCURATE. CONVENTIONAL INSTRUMENTS WERE USED TO COMPLETE THE PROEDURE AND MAKE THE DISTAL FEMUR AND TIBIA CUTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19772938 ↗
• MalfunctionMar 28, 2024Material Discolored; Contamination /Decontamination Problem; Material Discolored; Contamination /Decontamination Problem

  CUSTOMER IS REPORTING "SOMETHING LIKE BLOOD" ATTACHED TO THE BACKSIDE OF THE REFERENCE SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18998663 ↗
• MalfunctionMar 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  SURGEON REPORTED CUTS ARE WAY OFF AND REFERENCE SENSOR IS NOT GIVING ANY ERRORS OR INDICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18921773 ↗
• MalfunctionFeb 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE SURGEON FELT THE V/V ANGLE ON THE FEMUR WAS NOT ACCURATE. THE KNEE TURNED OUT WELL AND THERE WAS NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18676871 ↗
• MalfunctionDec 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE SURGEON REPORTED NOT BEING SATISFIED WITH THE FEMORAL RESECTION DUE TO POSSIBLE MISCALCULATION OF V/V. PATIEN HAD TO BE TAKEN BACK IN FOR REALIGNMENT AFTER POST-OP X-RAY.

  Patient problems: Joint Laxity

  MAUDE report 18270454 ↗
• MalfunctionDec 5, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE FLEXION/EXTENSION NUMBERS ARE NOT MAKING SENSE ONCE ATTACHED TO THE FEMUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18270450 ↗
• MalfunctionJul 25, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED TTHAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED WITH KNEEALIGN2 ON (B)(6) 2023 AND THE CUTTING BLOCK POSITIONED IN LARGELY VALGUS, ALTHOUGH THE KNEEALIGN FEMORAL SIDE WAS SET TO 0 DEGREE VARUS/CALGUS AND 3 DEGREES OF FLEXION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17391005 ↗
• MalfunctionApr 26, 2023Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  SURGEON REPORTED THAT HE IS UNHAPPY WITH THE INFORMATION/VALUES BEING GIVEN FOR THE FEMORAL SIDE, AND HE BELIEVES THERE IS A FAULT WITH THE SENSORS. UPDATED INFORMATION FROM THE ORTHALIGN CONTACT REPORTS THAT AFTER REGISTERING THE HIP CENTER AND PLACING THE CURRING BLOCK IN ZERO DEF. TO MECHANICAL AXIS, THAT THE TECHNOLOGY WAS PUTTING THE SURGEON IN SEVERE VALGUS OR VARUS, WHICH WOULDN'T MAKE SENSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820892 ↗
• MalfunctionAug 10, 2021No Apparent Adverse Event; No Apparent Adverse Event

  INACCURATE TIBIAL ALIGNMENT; THE VARUS/VALGUS NUMBERS DISPLAYED DID NOT MATCH ACTUAL ALIGNMENT OF THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12302007 ↗
• MalfunctionAug 5, 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. AFTER MANEUVER LEG AT FEMUR REGISTRATION, SURGEON ADJUSTED ANGLES. HOWEVER, CUT BLOCK POSITION WAS OBVIOUSLY TOO VALGOUS. SURGEON REMOVED THE FIXATION PINS AND INSERTED THEM TO FIX THE CUT BLOCK AGAIN. HOWEVER, THE SAME PROBLEM OCCURRED AGAIN. SUBSEQUENTLY, CONVENTIONAL INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284927 ↗
• MalfunctionJul 2, 2021Non Reproducible Results; Non Reproducible Results

  IT WAS REPORTED THAT THE SURGEON IS CLAIMING INACCURATE READINGS ON FEMUR REGISTRATIONS FOR THE REFERENCE SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12109456 ↗
• MalfunctionJul 2, 2021Non Reproducible Results; Non Reproducible Results

  IT WAS REPORTED THAT THE SURGEON IS CLAIMING INACCURATE READINGS ON FEMUR REGISTRATIONS FOR ALL THREE SENSORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12109455 ↗
• MalfunctionJul 2, 2021Non Reproducible Results; Non Reproducible Results

  IT WAS REPORTED THAT THE SURGEON IS CLAIMING INACCURATE READINGS ON FEMUR REGISTRATIONS FOR ALL THREE SENSORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12109453 ↗
• 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 (RIGHT AND LEFT KNEES) WAS PERFORMED WITH KNEEALIGN. AFTER COMPLETED FEMUR REGISTRATION, THE SURGEON PERFORMED DISTAL FEMUR OSTEOTOMY BY THE ADJUSTED ANGLES. HOWEVER, THE FEMUR BONE WAS CUT AT OVER EXTENSION POSITION. SUBSEQUENTLY, CONVENTIONAL INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE. THIS INCIDENT OCCURRED AT LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12099225 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON FEEDBACK THAT THE KNEE CUT WAS VALGUS AFTER CHECKING X RAY (POST-OP).

  Patient problems: Joint Laxity

  MAUDE report 12097329 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON FEEDBACK THAT THE KNEE CUT WAS VALGUS AFTER CHECKING X RAY (POST-OP).

  Patient problems: Joint Laxity

  MAUDE report 12097327 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON FEEDBACK THAT THE KNEE CUT WAS VALGUS AFTER CHECKING X RAY (POST-OP).

  Patient problems: Joint Laxity

  MAUDE report 12097326 ↗
• InjuryJun 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON FEEDBACK THAT THE KNEE CUT WAS VALGUS AFTER CHECKING X RAY (POST-OP).

  Patient problems: Joint Laxity

  MAUDE report 12097325 ↗