VANGUARD 360 REVISION SYSTEMRecalls & reported problems across all models
Biomet Orthopedics, LLC · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 1
We found 4 models of VANGUARD 360 REVISION SYSTEM by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Dec 21, 2021 and Feb 24, 2025 — classified as 3 injuries.
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
VANGUARD 360 REVISION SYSTEM recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 1, 2020Terminated
Incorrect bolt -tibial bolts in package instead of femoral bolts may delay procedure
Z-0723-2021 · Root cause: Process control · Recall details · FDA record ↗
Most reported VANGUARD 360 REVISION SYSTEM problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Pain3
- Ambulation or Postural Difficulties2
- Blister1
- Chills1
- Depression1
- Dizziness1
- Eczema1
- Hypersensitivity/Allergic reaction1
VANGUARD 360 REVISION SYSTEM models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VANGUARD 360 REVISION SYSTEM 185422PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- VANGUARD 360 REVISION SYSTEM 185305Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 report
- VANGUARD 360 REVISION SYSTEM 185344Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 report
- VANGUARD 360 REVISION SYSTEM 185346Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 report
Recent VANGUARD 360 REVISION SYSTEM adverse event reports
The 3 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT IS EXPERIENCING PAIN AND AMBULATION DIFFICULTIES APPROXIMATELY TWO YEARS AND TWO AND A HALF MONTHS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Ambulation or Postural Difficulties; Pain
MAUDE report 21448147 ↗InjuryJun 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 17133926 ↗InjuryDec 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT IS EXPERIENCING PAIN, SWELLING, LOSS OF RANGE OF MOTION, INSTABILITY, DIFFICULTY AMBULATING, AND FALLING DUE TO HER KNEE LOCKING UP APPROXIMATELY 18 MONTHS POST-IMPLANTATION. NO REVISION PROCEDURE HAS BEEN REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: Ambulation or Postural Difficulties; Inflammation; Pain; Swelling/ Edema
MAUDE report 13052276 ↗
Other Biomet Orthopedics, LLC products
- AFFIXUSHIP FRACTURE NAIL - RIGHT39 models · 6 reports · 37 recalls
- AFFIXUSHIP FRACTURE NAIL - LEFT27 models · 7 reports · 24 recalls
- Compress Device71 models · 99 reports · 22 recalls
- Arcos Modular Revision Hip System71 models · 191 reports · 19 recalls
- Comprehensive Reverse Shoulder57 models · 895 reports · 3 recalls
- Vanguard Knee System147 models · 306 reports · 13 recalls
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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