BIOMET 360 KNEE SYSTEM 185211Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304459519), received between Jun 10, 2020 and Jan 15, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, ON AN UNKNOWN TIMEFRAME POST-IMPLANTATION, THE OFFSET STEM COUPLER DISSOCIATED FROM THE FEMORAL COMPONENT. THE PATIENT UNDERWENT REVISION SURGERY AND ALL FEMORAL COMPONENTS WERE REPLACED WITHOUT REPORTED COMPLICATION. IT WAS REPORTED THAT ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 24080097 ↗
• InjuryJun 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING A REVISION PROCEDURE, THE PATIENT EXPERIENCED PAIN, SWELLING AND FALLING. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Fall; Pain; Swelling

  MAUDE report 10140279 ↗

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