BIOMET 360 KNEE SYSTEM 185651Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304525764), received between Jul 28, 2021 and Mar 25, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K093293, K140883); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY SIX YEARS POST IMPLANTATION DUE TO PAIN. BONE SCANS PRIOR TO REVISION SUGGEST INFECTION, STRESS RESPONSE. NO FURTHER RECORDS PROVIDED.

  Patient problems: Pain

  MAUDE report 21688283 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY TWENTY-TWO MONTHS POST IMPLANTATION DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 14986816 ↗
• InjuryJul 28, 2021Unstable; Unstable

  UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS IDENTIFIED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. PLEASE VOID REPORT.

  Patient problems: Joint Laxity

  MAUDE report 12237908 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093293, K140883. 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