Vanguard M Partial Knee System US154703Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304180642), received between Aug 23, 2021 and Oct 11, 2023 — classified as 2 injuries.

2 other recalls cover devices cleared under the same FDA submission (K021621, K042093); 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. 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.

• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE MANIPULATION UNDER ANESTHESIA TO TREAT STIFFNESS AND LIMITED RANGE OF MOTION APPROXIMATELY THREE (3) MONTHS FOLLOWING RIGHT UNICOMPARTMENTAL KNEE ARTHROPLASTY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 17916778 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL RIGHT PARTIAL KNEE ARTHROPLASTY PERFORMED. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION APPROXIMATELY 2 WEEKS POST-OP DUE TO TIBIAL PLATEAU FRACTURE. THE PATIENT COMPLETED THE STUDY DUE TO DEVICE REMOVAL. CONVERTED TO TOTAL KNEE ARTHROPLASTY WITHOUT COMPLICATIONS.

  Patient problems: Bone Fracture(s)

  MAUDE report 12352820 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021621, K042093. One submission often covers many models, so check the product and lot details in each record.

• Z-2155-2020 · Apr 17, 2020 · Terminated
  Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vanguard M Partial Knee System MonoBlock Tibial Tra
• Z-1798-2015 · Apr 22, 2015 · Terminated
  Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.