VANGUARD COMPLETE KNEE SYSTEM 195911Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304560352), received between Nov 27, 2019 and Jun 26, 2020 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K141407); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 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.

• InjuryJun 26, 2020Adverse 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: Pain

  MAUDE report 10200613 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT REPORTED A DECREASE IN FLEXION AND INCREASE IN PAIN AND STIFFNESS APPROXIMATELY ONE-YEAR POST IMPLANTATION. NO REVISION OR INTERVENTION HAS BEEN NOTED AT THIS TIME. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Muscular Rigidity; Pain

  MAUDE report 9382657 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141407. One submission often covers many models, so check the product and lot details in each record.

• Z-1265-2016 · Feb 5, 2016 · Terminated
  Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncement