OrthAlign Plus 403001-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00851977007901), received between May 6, 2019 and Sep 2, 2022 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (9 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE UNIT WAS USED FOR THE TIBIA CUT, THEN WHEN BEING USED FOR THE FEMORAL CUT, THE SURGEON THOUGHT THE ALIGNMENT OF THE FEMORAL BLOCK WAS NOT IN AN ACCURATE POSITION ON 2 ATTEMPTS. A NEW UNIT WAS OPENED, AND CASE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352772 ↗
• MalfunctionAug 10, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE UNIT REGISTERED FEMUR CORRECTLY, SURGEON DIALED IN 0/0 VARUS VALGUS BUT WHEN CHECKED WITH MANUAL INSTRUMENTATION FEMUR CUT BLOCK WAS SITTING IN "SEVERAL DEGREES OF VALGUS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200195 ↗
• InjuryJun 26, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE FEMORAL AND TIBIA CUTS WERE MADE USING THE ORHALIGN COMPUTER. AFTER COMPLETION OF CUTS THE SURGEON THOUGHT THE TIBIA CUT LOOKED LIKE IT HAD AN ANTERIOR SLOPE OF AROUND 10 DEGREES (THE JIG WAS DIALED TO ZERO DEGREES V/V AND ZERO DEGREES POSTERIOR SLOPE). HE ALSO THOUGHT THE FEMORAL CUT WAS IN TOO MUCH FLEXION + IN VARUS (JIG WAS SET TO ZERO GEGREES V/V AND 3 DEGREES FEM FLEXION). TIBIA HAD TO BE RECUT WITH EXTRAMEDULLARY GUIDE.

  Patient problems: Joint Laxity

  MAUDE report 14824878 ↗
• MalfunctionMay 25, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHEN DR. (B)(6) SET HIS FLEXION ON THE DISTAL CUT AT FOUR DEGREES. IT LOOKED LIKE MORE LIKE 18-20 DEGREES. WE DID A MANUAL KNEE AT THAT POINT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14502658 ↗
• MalfunctionAug 9, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT TOTAL HIP ARTHROPLASTY WAS PERFORMED WITH HIPALIGN IN THE MORNING WITH THE NAVIGATION UNIT AND REFERENCE SENSOR. WHILE THE SURGEON WAS IMPACTING CUP, ABDUCTION ANGLES WAS BIGGER AND BIGGER SUCH AS FROM 60 TO 70 DEGREES. HE IMPACTED THE CUP AGAIN, ANGLES THE NAVIGATION SHOWED WAS PROPER SUCH AS 40 DEGREE AND 15 DEGREE. THE ONLY ABDUCTION ANGLES BECAME BIGGER WHEN IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12294353 ↗
• InjuryJul 1, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER FEMORAL REGISTRATION THE UNIT READ 24 DEGREES OF FLEXION. FEMORAL PIN WAS REINSERTED AND RANGE OF MOTION WAS REDONE. UNIT READ 15 DEGREES OF FLEXION AND THE SURGEON WAS ABLE TO ADJUST THE CUTTING BLOCK UNTIL THE UNIT READ 5 DEGREES OF EXTENSION. AFTER CUT WAS MADE THE SURGEON NOTICED THAT THE CUT "DIDNT LOOK RIGHT" AN IM GUIDE WAS USED TO REDO THE CUT. ITEM WORKED NORMALLY ON THE TIBIA AND THE CASE WAS COMPLETED WITH NO OTHER ISSUES. THE FEMORAL REGISTRATION WAS STARTED WITH THE LEG IN FLEXION. THIS WAS THE ONLY POSITION THE ALLOWED THE UNIT TO SHOW THE GREEN BOX.

  Patient problems: Joint Laxity

  MAUDE report 12099233 ↗
• MalfunctionJun 24, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT TOTAL HIP ARTHROPLASTY WAS PERFORMED WITH HIPALIGN. CUP ANGLES, ESPECIALLY ABDUCTION CHANGED A LOT AFTER CUP IMPACTION. THE ANTEVERSION ANGLE ALSO CHANGED AS WELL. HE CONFIRMED FIXATION OF THE UNIT AND THE REFERENCE SENSOR BUT NO LOOSE WAS FOUND AT THAT TIME. SUBSEQUENTLY, HE COMPLETED THE SURGERY WITH ANGLES THE NAVIGATION FIRSTLY SHOWED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12059056 ↗
• MalfunctionJun 16, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED WITH KNEE ALIGN. WHEN SURGEON CHECKED THE PATIENT'S FEMUR BONE AND DISTAL OSTEOTOMY SURFACE WITH IMAGE DURING SURGERY, HE FOUND THAT THE VALGUS ANGLE WAS TOO MUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12010610 ↗
• MalfunctionDec 12, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT TOTAL HIP ARTHROPLASTY WAS PERFORMED WITH HIPALIGN (ALS APPROACH). THE SURGEON SET THAT ABDUCTION ANGLE WAS 40 DEGREE WITH THE NAVIGATION SYSTEM. HOWEVER, HE FOUND THAT THE ANGLE WAS DIFFERENT BY FROM 10 TO 15 DEGREES BY IMAGE. THEN, HE IMPACTED A CUP IN ACCORDANCE WITH THE IMAGE THREE TIMES (THE TARGETED ABDUCTION ANGLE 40 DEGREE) AND THE CUP WAS INSTALLED. AFTER THAT, ANGLES THE NAVIGATION SHOWED WERE ABDUCTION 52 DEGREES AND ANTEVERSION 25 DEGREES AND ABDUCTION 50 DEGREES AND ANTEVERSION 22 DEGREES. THE INSTALLED CUP ANGLE WAS CORRECT BY THE SURGEON'S POSTOPERATIVE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10997058 ↗
• MalfunctionNov 4, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT WHEN NAVIGATING THE CUP THE VERSION AND ABDUCTION OUTPUTS WERE COMPLETELY INCORRECT. THE VERSION OF THE CUP AND ABDUCTION WERE CONFIRMED TO BE CORRECT BY THE SURGEON INTRAOPERATIVELY USING C-ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10786293 ↗
• MalfunctionAug 11, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT TOTAL HIP ARTHROPLASTY WAS PERFORMED WITH HIPALIGN, SUPINE APPROACH. THE SURGEON PLANNED THAT TARGET CUP ANGLE WAS 40/15 DEGREES. THE PROCEDURE WAS PROCEEDED IN ACCORDANCE WITH THE TARGET CUP ANGLE. AFTER CUP IMPACTION, THE NAVIGATION SHOWED THAT THE CUP WAS INSTALLED WITH 39/14 DEGREES (CUP ANGLE). POSTOPERATIVELY, HE CONFIRMED X-RAY PHOTOS OF THE CUP ANGLE AND ABDUCTION ANGLE OF THE CUP WAS 56 DEGREES.

  Patient problems: Joint Laxity; No Known Impact Or Consequence To Patient

  MAUDE report 10394279 ↗
• MalfunctionSep 13, 2019Incorrect Measurement; Insufficient Device Problem Information; Incorrect Measurement; Insufficient Device Problem Information

  AS REPORTED BY THE DISTRIBUTOR/INITIAL REPORTER: VALUES GIVEN BY THE NAVIGATION UNIT WERE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 9050624 ↗
• MalfunctionAug 29, 2019Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event; Incorrect, Inadequate or Imprecise Result or Readings; No Apparent Adverse Event

  (B)(4). THE UNIT WAS GIVING VERY INACCURATE LEG LENGTH. ALL PROCEDURES WERE BELIEVED TO HAVE BEEN PROPERLY EXECUTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 8946198 ↗
• MalfunctionMay 6, 2019No Apparent Adverse Event; No Apparent Adverse Event

  NAVIGATION UNIT ((B)(4)) GAVE A FLEXION READING OF 18 DEGREES, THIS IS EXTREME AND UNABLE TO TRAVEL THAT MUCH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8584230 ↗
• MalfunctionMay 6, 2019Incorrect Measurement; No Apparent Adverse Event; Incorrect Measurement; No Apparent Adverse Event

  NAVIGATION UNIT ((B)(4)) GAVE A FLEXION READING OF 11 DEGREES, EXTREME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 8584229 ↗