Biomet® 360 Knee System 185203Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304481428), received between Oct 22, 2020 and Jun 15, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 18, 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.

• MalfunctionJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Blister; Chills; Depression; Dizziness; Eczema; Hypersensitivity/Allergic reaction; Pain; Rash

  MAUDE report 17133938 ↗
• 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 14986843 ↗
• MalfunctionOct 22, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT A TOTAL KNEE ARTHROPLASTY WAS PERFORMED WITH VANGUARD 360. DURING PROCEDURE, THE SURGEON TRIED TO INSERT LOCKING BAR TO TIBIAL PLATE. HOWEVER, HE WAS UNABLE TO INSERT IT FIRMLY. SUBSEQUENTLY, ANOTHER LOCKING BAR WAS USED TO COMPLETE THE PROCEDURE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10718840 ↗

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-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