VANGUARD 32-360500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304516335), received between Oct 12, 2021 and May 9, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2024Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281086 ↗
• MalfunctionMar 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE POLY TRIAL CRACKED AFTER STERILIZATION. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839549 ↗
• MalfunctionJul 5, 2022Fracture; Fracture

  IT WAS REPORTED THE POLY TRIAL WAS FOUND BROKEN IN THE TRAY. WE DIDN'T NEED THAT SIZE SO NO DELAY OR REPLACEMENT WAS NEEDED DURING THE CASE. NO PATIENT IMPCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14917161 ↗
• MalfunctionOct 12, 2021Fracture; Fracture

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616601 ↗

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-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-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-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