Vanguard® Vivacit-E® VE189100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024564633), received between Jan 2, 2025 and Nov 25, 2025 — classified as 3 malfunctions.

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

• MalfunctionNov 25, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING FINAL TESTING OF THE FINAL BEARING IMPLANT, THE SURGEON DETERMINED THAT THE KNEE WAS UNSTABLE, HOWEVER, THE KNEE FELT STABLE DURING TRIALING. THE SURGEON REMOVED THE FINAL BEARING AND NOTICED THAT THE POSTERIOR LIP HAD DAMAGED THAT APPEARED TO BE MELTING OR DISFIGURED. THE SURGEON USED A NEW BEARING TO COMPLETE THE SURGERY ENSURING KNEE STABILITY. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645052 ↗
• MalfunctionJun 30, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING FINAL TESTING OF THE FINAL BEARING IMPLANT, THE SURGEON DETERMINED THAT THE KNEE WAS UNSTABLE, HOWEVER, THE KNEE FELT STABLE DURING TRIALING. THE SURGEON REMOVED THE FINAL BEARING AND NOTICED THAT THE POSTERIOR LIP HAD DAMAGED THAT APPEARED TO BE MELTING OR DISFIGURED. THE SURGEON USED A NEW BEARING TO COMPLETE THE SURGERY ENSURING KNEE STABILITY. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357476 ↗
• MalfunctionJan 2, 2025Packaging Problem; Packaging Problem

  IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT UPON OPENING UP THE ARTICULAR SURFACE IMPLANT, THE DEVICE WAS IDENTIFIED TO HAVE A HAIR ON IT WITHIN THE PACKAGING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21055955 ↗