OrthAlign Plus 403001-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810832030072), received between Sep 13, 2019 and Sep 10, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SURGEON STATED THAT THE NUMBERS SEEMED REVERSED FOR ABDUCTION AND VERSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457218 ↗
• MalfunctionMay 28, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED CUP ANGLE VALUES WERE OPPOSITE/DIFFERENT THAN WHAT WAS EXPECTED. WENT THROUGH CHECKLIST OF POTENTIAL REASONS, AND ALL WAS DONE CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11904394 ↗
• MalfunctionMar 18, 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. ABDUCTION ANGLE WAS INCORRECT. AFTER SURGEON SET ABDUCTION ANGLE 40 AND 15 DEGREES, HE INSTALLED A CUP. THEN, THE NAVIGATION UNIT SHOWED THAT THE ANGLE WAS 60 DEGREE BUT IMAGE SHOWED ABOUT 40 DEGREE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11517178 ↗
• MalfunctionFeb 25, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT AFTER REGISTRATION TOOK PLACE AND THE ACETABULUM WAS PREPARED, THE DEFINITIVE CUP WAS LOADED ON THE INSERTER. ONCE IN POSITION TO NAVIGATE, THE NUMBERS GIVEN BY THIS UNIT WAS OFF DRAMATICALLY. DR. (B)(6) WAS UNABLE TO USE THE UNIT AS A GUIDE DUE TO THE DISPARITY. HE ALSO TRIED TO USE IT FOR THE LEG LENGTH PORTION AND AGAIN FOUND THE NUMBERS TO BE OFF DRAMATICALLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11382591 ↗
• MalfunctionSep 13, 2019Patient Data Problem; Patient Data Problem

  AS DESCRIBED BY THE INITIAL REPORTER: "DR. (B)(6) HAD A CASE IN WHICH THE SUMMARY SCREEN DISPLAYED A 0.0 FOR THE APP ANTEVERSION VALUE, WHICH DID NOT SEEM TO MATCH WHAT HE PREVIOUSLY NAVIGATED TO. (B)(6) PROVIDED NOTES TO ACTUAL VALUE RECORDED DURING PROCEDURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9050734 ↗