VANGUARD 360 REVISION SYSTEM 185305Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00880304482265), received between Dec 21, 2021 and Dec 21, 2021 — classified as 1 injury.

5 other recalls cover devices cleared under the same FDA submission (K093293); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS EXPERIENCING PAIN, SWELLING, LOSS OF RANGE OF MOTION, INSTABILITY, DIFFICULTY AMBULATING, AND FALLING DUE TO HER KNEE LOCKING UP APPROXIMATELY 18 MONTHS POST-IMPLANTATION. NO REVISION PROCEDURE HAS BEEN REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Pain; Swelling/ Edema

  MAUDE report 13052276 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093293. One submission often covers many models, so check the product and lot details in each record.

• Z-0723-2021 · Dec 1, 2020 · Terminated
  Vanguard 360 Revision System Posterior Augment With Bolt - Product Usage: intended for use in knee arthroplasty Item Number: 185422
• Z-3250-2018 · Aug 2, 2018 · Terminated
  Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 Intended for use in Total Knee Arthroplasty
• Z-3249-2018 · Aug 2, 2018 · Terminated
  Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
• Z-0003-2017 · Aug 8, 2016 · Terminated
  Vanguard 360 Revision Knee System Knee prostheses
• Z-2242-2014 · Jul 1, 2014 · Terminated
  Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 4658