BIOMET 360 KNEE SYSTEMRecalls & reported problems across all models
Biomet Orthopedics, LLC · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls
- 0
We found 13 models of BIOMET 360 KNEE SYSTEM by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Oct 31, 2019 and Sep 23, 2026 — classified as 27 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (5 reports).
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
Most reported BIOMET 360 KNEE SYSTEM problems
Device problems
- Adverse Event Without Identified Device or Use Problem13
- Difficult to Insert5
- Insufficient Device Problem Information4
- Loosening of Implant Not Related to Bone-Ingrowth3
- Migration3
- Unstable3
- Corroded2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Pain18
- Ambulation or Postural Difficulties6
- Failure of Implant4
- Insufficient Information3
- Loss of Range of Motion3
- No Clinical Signs, Symptoms or Conditions3
- No Code Available3
- Blister2
BIOMET 360 KNEE SYSTEM models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Biomet® 360 Knee System 185204Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer5 reports
- BIOMET 360 KNEE SYSTEM 185650PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER4 reports
- Biomet® 360 Knee System 185202PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- Biomet® 360 Knee System 185203PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- BIOMET 360 KNEE SYSTEM 185651PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- BIOMET 360 KNEE SYSTEM 185210Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer2 reports
- BIOMET 360 KNEE SYSTEM 185211Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer2 reports
- Biomet® 360 Knee System 185201PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- Biomet® 360 Knee System 185206Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer2 reports
- BIOMET 360 KNEE SYSTEM 185221Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer2 reports
- BIOMET 360 KNEE SYSTEM 185233Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer2 reports
- BIOMET 360 KNEE SYSTEM 185212PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- BIOMET 360 KNEE SYSTEM 185224PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Recent BIOMET 360 KNEE SYSTEM adverse event reports
The 15 most recent reports across all models, 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 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 ↗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 ↗InjuryJan 6, 2026Corroded
IT WAS REPORTED PATIENT HAS METALLOSIS ON LEFT KNEE APPROXIMATELY 12 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 23973039 ↗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 ↗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 21688266 ↗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 21688263 ↗MalfunctionNov 14, 2024Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20684577 ↗InjuryMay 31, 2024Adverse 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: Balance Problems; Inflammation; Loss of Range of Motion; Muscle Weakness/Atrophy; Pain; Scar Tissue; Swelling/ Edema
MAUDE report 19435788 ↗InjuryNov 21, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain
MAUDE report 18184212 ↗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 ↗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 17133923 ↗InjurySep 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY TWENTY-TWO MONTHS POST IMPLANTATION DUE TO PAIN.
Patient problems: Pain
MAUDE report 15363476 ↗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 ↗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 14986824 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page