Vanguard® Vivacit-E® VE189040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024564428), received between May 18, 2022 and Nov 13, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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.

• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Ambulation or Postural Difficulties; Ankylosis; Arthrofibrosis; Cyst(s); Loss of Range of Motion; Nerve Damage; Neuropathy; Pain; Swelling/ Edema

  MAUDE report 23548838 ↗
• InjuryMay 18, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT HAD A FALL AND UNDERWENT A REVISION AS THE SURGEON HAD THOUGHT THE LOCKING PIN HAD BROKE. DURING SURGERY, IT WAS DISCOVERED THAT THE LOCKING BAR HAD NOT FRACTURED BUT THEY FELT THAT THE POLY DID GET A LITTLE DEFORMED. THEY REPLACED THE IMPLANT WITH A NEW POLY AND LOCKING BAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Fall

  MAUDE report 14429587 ↗