VELYS 451580052Recalls & reported problems
Depuy (Ireland) · VELYS HIP NAVIGATION iOS VERSION X · Class 2
All models of VELYS (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295532040), received between Aug 29, 2022 and Nov 3, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (3 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.
Reports received per month
Most reported problems
Device problems
- Computer Software Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 3, 2023Computer Software Problem; Computer Software Problem
IT WAS REPORTED THAT THE SOFTWARE IS NOT ALIGNING CORRECTLY IN SURGERIES, SPECIFICALLY ON THE SHOULDERS. THE ISSUE IS WITH THE LEG LENGTH AND OFFSET ON HIPS WHILE USING THE EMPHASYS STEM, AND NUMBERS ARE OFF. THERE ARE ISSUES WITH HAVING TO UNINSTALL, REINSTALL, REQUEST FOR MULTIPLE PASSWORD RESETS AND HAVING TO EXECUTE THIS FORM OF TROUBLESHOOTING DAILY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18067696 ↗MalfunctionJul 16, 2023Computer Software Problem; Computer Software Problem
IT WAS REPORTED THAT : 1) VELYS HIP NAVIGATION VHN SCREEN HAS POOR RESOLUTION. 2) VHN MODIFIED CUP POSITION WENT OFF OF INCORRECT ANGLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17330841 ↗MalfunctionAug 29, 2022Computer Software Problem; Computer Software Problem
IT WAS REPORTED THAT "SALES REP SENT A SCREENSHOT AFTER A CASE OF THE RESULTS THAT WERE DISPLAYED IN THE PATIENT CHART ONLY OF VHN, AND NOT DURING THE ACTUAL PROCEDURE. THE IMAGE ON VHN SHOWS ALL SIZE / OFFSET OPTIONS AVAILABLE INSTEAD OF JUST ONE ¿ ONE APPEARS TO BE INCORRECT IN THE CHART. NOTHING WAS DISPLAYED INCORRECTLY DURING THE PROCEDURE ¿ JUST ON THE CHART RECORD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15309772 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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