OrthAlign Plus 403001-04Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00851977007734), received between Apr 13, 2019 and Aug 5, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2021Use of Device Problem; Use of Device Problem

  SETTING MICROBLOCK WAS OK, QUANTITY OF OSTEOTOMY WAS VERY DIFFERENT FROM QUANTITY THE SURGEON HAD PLANNED. FIRST FIXATION PINS WERE RE-INSERTED TO RETRY THE FEMUR REGISTRATION. HOWEVER, SURGEON WAS UNABLE TO COMPLETE THE REGISTRATION 20 TIMES. AFTER THAT, THE NAVIGATION UNIT BATTERY TURNED OFF AND COULD NOT BE REBOOTED. SUBSEQUENTLY, CONVENTIONAL INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE FAILURE COULD NOT BE REPRODUCED. ACCORDING TO THE NAVIGATION UNIT EVENT LOG, THE USER REPEATEDLY SAW AN INCONSISTENT HIP POINT ERROR WHILE ATTEMPTING THE FEMORAL MANEUVER; THIS ASPECT OF THE COMPLAINT CAN BE CONFIRMED. THIS ERROR CAN ALSO OCCUR IF THE SYSTEM IS UNABLE TO DETERMINE WHERE THE FEMORAL HEAD RESIDES BASED ON THE MANEUVER PERFORMED. ORTHALIGN, INC. WILL CONTINUE TO MONITOR THIS ISSUE AND TAKE ACTION WHEN/IF ALERT LIMITS ARE EXCEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12284411 ↗
• MalfunctionJun 30, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED WITH KNEEALIGN. THE SURGEON ALLEGED THAT OSTEOTOMY ANGLE FOR DISTAL FEMORAL WAS NOT PROPER. SUBSEQUENTLY, CONVENTIONAL INSTRUMENTS WERE USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12097283 ↗
• MalfunctionApr 3, 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 IN THE AFTERNOON 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. ONLY THE ABDUCTION ANGLES BECAME BIGGER WHEN IMPACTED.

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

  MAUDE report 9923332 ↗
• MalfunctionApr 13, 2019No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT A NAVIGATION UNIT PREPARED FOR TOTAL HIP ARTHROPLASTY WAS PERFORMED WITH ORHALIGN PLUS NAVIGATION. AFTER CUP INSTALLATION, THE UNIT DISPLAY SUDDENLY BECAME BLACK AND THE DISPLAY WENT BACK TO OPENING SCREEN. ALSO, AFTER PRELIMINARY CUP FIXATION, THE SURGEON FOUND ACTUAL ANGLE SHOWED IN X-RAY WAS DIFFERENT FROM THE ANGLE THE NAVIGATION SHOWED. (7 DEGREES) PRELIMINARY CUP FIXATION: ABDUCTION 40 DEGREE. X-RAY PHOTO: ABDUCTION 33 DEGREE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8512163 ↗