Vanguard® Vivacit-E® VE189064Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024564534), received between Feb 1, 2024 and Aug 28, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 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: Joint Laxity; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 22911571 ↗
• InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO YEARS AND FOUR MONTHS POST IMPLANTATION DUE TO PAIN, INSTABILITY, EFFUSIONS, AND PATELLA IMPINGEMENT WITH MALALIGNMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Joint effusion; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 19710601 ↗
• InjuryFeb 1, 2024Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO YEARS AND FOUR MONTHS POST IMPLANTATION DUE TO PAIN, INSTABILITY, EFFUSIONS, AND PATELLA IMPINGEMENT WITH MALALIGNMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Joint effusion; Muscle Weakness/Atrophy; Pain

  MAUDE report 18623302 ↗