Vanguard® Vivacit-E® VE183661Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024565746), received between Oct 15, 2025 and Dec 4, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AFTER INSTALLING THE BEARING, THE LOCKING BAR DIDN'T GO STRAIGHT IN AND COULD NOT BE SEATED IN THE TIBIAL TRAY. STAFF NOTICED THAT THE BOTTOM SURFACE OF THE BEARING WAS NOT FLAT AND IT TILTED LIKE A SEESAW WHEN PLACED ON THE TIBIAL TRAY. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS LESS THAN A 30 MINUTE DELAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23715983 ↗
• MalfunctionOct 15, 2025Positioning Failure; Positioning Failure

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302390 ↗