Biomet® 360 Knee System 185204Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304481435), received between Jan 12, 2021 and Sep 23, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Difficult to Insert

  It was reported that the locking bar didn't fit in the bearing and the tibial tray, so the surgery was completed with a new locking bar. The surgeon suspected that the locking bar and bearing might have been deformed prior to use as they could not smoothly insert the locking bar into the tibial plate. There was a less than 30 minute surgical delay. The surgical technique was utilized. Attempts have been made and all available information has been provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867958 ↗
• InjuryJan 6, 2026Corroded

  IT WAS REPORTED PATIENT HAS METALLOSIS IN RIGHT KNEE APPROXIMATELY 10 YEARS POST IMPLANTATION. NO INTERVENTION HAS BEEN REPORTED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Ambulation or Postural Difficulties; High metal ion levels; Metal Related Pathology

  MAUDE report 23973114 ↗
• InjuryOct 13, 2021Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Ambulation or Postural Difficulties; Failure of Implant; Loss of Range of Motion; Pain; Peripheral Nervous Injury

  MAUDE report 12623636 ↗
• InjuryJun 28, 2021Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

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

  Patient problems: Failure of Implant

  MAUDE report 12076445 ↗
• InjuryJan 12, 2021Migration; Migration

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

  Patient problems: Osteopenia/ Osteoporosis; Pain

  MAUDE report 11156394 ↗

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