VELYS 451580051Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295522850), received between Oct 9, 2020 and Oct 12, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (5 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.

• MalfunctionOct 12, 2023Computer Software Problem; Computer Software Problem

  CONSIGNMENT VHN TOWER. (B)(6). SERIAL NO 14.) REMAINS FUNCTIONAL. IT CONNECTS TO THE INTRA-OPERATIVE IMAGING C-ARM VIA BNC CABLE & LUNA BOX. REP WAS ABLE TO DIRECT IMPORT IMAGES FROM C-ARM TO VHN TOWER AS PER STANDARD PROCEDURE. THE QUALITY OF THE IMAGES FOLLOWING THE TRANSFER DIRECT IMPORT SINCE THE MOST RECENT VHN UPDATE ON (B)(6) 2023 WAS NOTICEABLY OVER-EXPOSED, HIDING CRITICAL ANATOMICAL LANDMARKING DATA POINTS REQUIRED TO CARRY OUT THE USE OF THE SOFTWARE. THE IMAGES APPEAR DIFFERENT TO THEY DO ON THE C-ARM SCREENS AS SEEN IN ATTACHED PHOTOS WITH THIS FORM. THE SURGEON WAS ABLE TO CARRY OUT THE REMAINING SURGERY. ACTION TAKEN WHEN EVENT OCCURRED: SURGEON CHECK POINT VERIFICATION ENFORCED WITH SOFTWARE. SURGEON DECIDED TO MAKE INTRA-OP DECISION BASED ON RE-TRIALING AND UTILIZING OTHER OBJECTIVE CLINICAL OUTCOMES. PROCEDURE SUCCESSFULLY COMPLETED WITH A 5 MINUTE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17919355 ↗
• MalfunctionMar 6, 2023Computer Software Problem; Computer Software Problem

  THE OFFSET LENGTHS FOR SOME S-ROM IMPLANT TEMPLATES ARE NOT CHANGING IN CORRESPONDENCE TO CHANGES IN STEM NECK LENGTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16484813 ↗
• MalfunctionOct 17, 2022Computer Software Problem; Computer Software Problem

  THE METADATA CORRESPONDING TO THE LEG LENGTH AND OFFSET FOR THE S-ROM STEM FAMILY ISN'T DISPLAYED CORRECTLY IN THE PRODUCTION ENVIRONMENT. THERE ARE ALSO DISCREPANCIES IN THE METADATA THAT CAUSE THE CENTER OF ROTATION FOR THE FEMORAL HEAD TO BE PLACED IN THE THE INCORRECT LOCATION. THIS WAS FOUND BY THE R&D TEAM AND A SOFTWARE UPDATE IS PLANNED FOR (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616404 ↗
• 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 15309773 ↗
• MalfunctionOct 9, 2020Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT THE ISSUE: ONE TRIAL ANALYSIS CHART DOES NOT CORRECTLY REFLECT THE CHANGE TO LEG LENGTH WHEN CHANGING BETWEEN PROXIMAL BODY HEIGHTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10655439 ↗