Vanguard Complete Knee System 195849Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304552555), received between Jan 13, 2021 and Jul 14, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 12165397 ↗
• InjuryJan 13, 2021Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT FELT A PAIN ON HER OPERATED KNEE JOINT AND SWELLING WAS CONFIRMED ON HER KNEE. THE SURGEON SUSPECTS WEAR AND DEFORMATION ON THE ARTICULAR SURFACE BECAUSE THE PATIENT ACTIVITY WAS VERY HIGH. AS A RESULT, A REVISION WAS PERFORMED TO REPLACE THE ARTICULAR SURFACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Pain; Swelling

  MAUDE report 11163482 ↗