OrthAlign Plus 403001-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00810832031369), received between Apr 7, 2022 and Jun 2, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 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 16, 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.

• MalfunctionJun 2, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  SENSOR UNIT WOULD NOT CALIBRATE WITH THE NAVIGATION UNIT. A NEW OA+ UNIT WAS OPENED AND THEN IT SUCCESSFULLY CALIBRATED WITH THE SENSOR UNIT. THE DISTAL FEMORAL CUT WAS OFF BY A SIGNIFICANT AMOUNT.

  Patient problems: Insufficient Information

  MAUDE report 17056149 ↗
• MalfunctionMar 21, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED WITH KNEEALIGN ON (B)(6), 2023. SURGEON FELT THAT THE OSTEOTOMY QUANTITY WAS NOT VISUALLYN PROPER. THEREFORE, HE SWITCHED TO CONVENTIONAL INSTRUMENTS TO COMPLETE THE PROCEDURE. THE NAVIGATION UNIT WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588441 ↗
• InjuryFeb 20, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2022. SURGEON DID THE FEMUR REGISTRATION AND INSTALLED THE GUIDE (V/V WAS ADJUSTED TO ZERO DEGREES) IN ACCORDANCE WITH THE PROCEDURE. HOWEVER, AFTER CUTTING THE DISTAL FEMUR BONE, SHE FOUND THAT IT WAS OBVIOUSLY VALGUS. SUBSEQUENTLY, SHE ADDITIONALLY CUT THE BONE TO ADJUST THE ALIGNMENT. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE.

  Patient problems: Joint Laxity

  MAUDE report 16401930 ↗
• MalfunctionFeb 16, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY THE USER PUT THE ORTHALIGN PLUS UNIT AND REFERENCE SENSOR ON THE FEMORAL MICROBLOCK. DID THE FEMORAL MOVE TO LOCATE HIP CENTER. A "NORMAL" LOOKING CUT READ 20 DEGREES OF F/E. WHEN THEY ADJUSTED THE CUTTING BLOCK SO THE SCREEN READ 0 DEGREES THE CUT LOOKED TO BE ABOUT -20 DEGREES IN F/E. THEY TOOK THE UNIT/SENSOR OFF AND POWERED DOWN TO RE-PAIR. AFTER THAT THE MOVE REGISTRATION WOULD NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16392070 ↗
• MalfunctionSep 27, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING CUP POSITIONING THE READ OUT OF NUMBERS SEEMED TO BE THE OPPOSITE OF WHAT THE SURGEON WAS DOING. THEY DOUBLE CHECKED THAT THE CORRECT SIDE WAS SELECTED AND THAT THE IMPACTOR ADAPTER WAS FACING THE CORRECT DIRECTION. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15490171 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED AND COMPONENTS WERE SUBMITTED IN PLACE. THE PHYSICIAN NOTICED A LARGE GAP IN THE LATERAL COMPARTMENT OF THE KNEE. HE HAD CONCERNS THAT THE UNIT MAY HAVE MALIGNED THE FEMUR, AND WANTED REVIEW OF THE DEVICE. THE COMPUTER WAS TAKEN OFF THE FIELD AND IT READ, "NAVIGATION UNIT ERROR, REPLACE WITH NEW NAV. UNIT, RETURN THIS UNIT... STUCK KEY 4."

  Patient problems: Joint Laxity

  MAUDE report 14042997 ↗