Vanguard Complete Knee SystemRecalls & reported problems across all models
Biomet Orthopedics, LLC · 27 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls
- 0
We found 27 models of Vanguard Complete Knee System by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Nov 27, 2019 and Jul 23, 2025 — classified as 31 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 Vanguard Complete Knee System problems
Device problems
- Adverse Event Without Identified Device or Use Problem20
- Device Dislodged or Dislocated5
- Loosening of Implant Not Related to Bone-Ingrowth3
- Migration3
- Loss of or Failure to Bond2
- Naturally Worn2
- Detachment of Device or Device Component1
- Difficult to Insert1
Patient problems
- Pain25
- Loss of Range of Motion6
- Joint Dislocation5
- Limited Mobility Of The Implanted Joint5
- Swelling/ Edema4
- Failure of Implant3
- Muscular Rigidity3
- No Clinical Signs, Symptoms or Conditions3
Vanguard Complete Knee System models
27 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Vanguard Complete Knee System 195849Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer2 reports
- VANGUARD COMPLETE KNEE SYSTEM 195757Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer2 reports
- VANGUARD COMPLETE KNEE SYSTEM 195753Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive2 reports
- VANGUARD COMPLETE KNEE SYSTEM 195911Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer2 reports
- VANGUARD COMPLETE KNEE SYSTEM 195919Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive2 reports
- Vanguard Complete Knee System 195877Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 report
- VANGUARD COMPLETE KNEE SYSTEM 195756PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Vanguard Complete Knee System 195842PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Vanguard Complete Knee System 195780Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 report
- Vanguard Complete Knee System 195854Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 report
- Vanguard Complete Knee System 195850PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Vanguard Complete Knee System 195810PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- VANGUARD COMPLETE KNEE SYSTEM 195772PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Vanguard Complete Knee System 195275PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- VANGUARD COMPLETE KNEE SYSTEM 195755Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 report
- Vanguard Complete Knee System 195269PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- VANGUARD COMPLETE KNEE SYSTEM 195754Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 report
- VANGUARD COMPLETE KNEE SYSTEM 195779Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 report
- Vanguard Complete Knee System 195808PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Vanguard Complete Knee System 195783PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Vanguard Complete Knee System 195271PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- VANGUARD COMPLETE KNEE SYSTEM 195557PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- VANGUARD COMPLETE KNEE SYSTEM 195909Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 report
- VANGUARD COMPLETE KNEE SYSTEM 195912Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 report
- VANGUARD COMPLETE KNEE SYSTEM 195924Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 report
- Vanguard® Complete Knee System 195543PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Vanguard® Complete Knee System 195610Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 report
Recent Vanguard Complete Knee System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 23, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION DUE TO PAIN AND POST-OPERATIVE WEAR AND FRACTURE OF THE POLYETHYLENE TIBIAL BEARINGS APPROXIMATELY FIVE (5) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Pain
MAUDE report 22576024 ↗InjuryJul 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT APPROXIMATELY 5 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION TO THE RIGHT KNEE DUE TO THE LOCKING BAR DISASSOCIATING. THE LOCKING BAR AND BEARING WERE REPLACED. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE AND NONE IS AVAILABLE.
Patient problems: Pain
MAUDE report 22412184 ↗InjuryOct 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA TWO (2) MONTHS FOLLOWING RIGHT KNEE ARTHROPLASTY TO ADDRESS PAIN, STIFFNESS, RESTRICTED RANGE OF MOTION AND CONCERN FOR ARTHROFIBROSIS. HOWEVER, THE PATIENT CONTINUED TO EXPERIENCE LIMITED RANGE OF MOTION AND WAS SUBSEQUENTLY REVISED. DURING THE REVISION, BOTH THE MEDIAL AND LATERAL TIBIAL BEARINGS WERE NOTED TO NOT BE FULLY SEATED AND THE LATERAL TIBIAL BEARING WAS PARTIALLY FRACTURED. ARTHROLYSIS AND DEBRIDEMENT WERE PERFORMED TO REMOVE SCAR TISSUE AND THE TIBIAL BEARINGS AND LOCKING BAR WERE REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Pain
MAUDE report 20515545 ↗InjuryFeb 2, 2024Migration; Migration
IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO THE LOCKING BAR BACKING OUT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18629717 ↗InjuryFeb 2, 2024Migration; Migration
IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO THE LOCKING BAR BACKING OUT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18629655 ↗MalfunctionJan 22, 2024Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE LOCKING BAR WOULD NOT SUCCESSFULLY MATE WITH THE TIBIAL INSERT. THE PROCEDURE WAS COMPLETED USING ANOTHER TIBIAL INSERT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18552388 ↗InjuryJan 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PATELLAR AND TIBIAL BEARING DISLOCATION AND PAIN APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. THE PATIENT'S PATELLA WAS RESURFACED AND THE TIBIAL BEARINGS WERE REPLACED. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation; Pain
MAUDE report 18464370 ↗InjuryJan 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PATELLAR AND TIBIAL BEARING DISLOCATION AND PAIN APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. THE PATIENT'S PATELLA WAS RESURFACED AND THE TIBIAL BEARINGS WERE REPLACED. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation; Pain
MAUDE report 18464350 ↗InjuryJan 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PATELLAR AND TIBIAL BEARING DISLOCATION AND PAIN APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. THE PATIENT'S PATELLA WAS RESURFACED AND THE TIBIAL BEARINGS WERE REPLACED. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation; Pain
MAUDE report 18464344 ↗InjuryJan 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN AND DISLOCATION OF THE FEMORAL COMPONENT AND TIBIAL BEARINGS APPROXIMATELY TWO (2) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation; Pain
MAUDE report 18464343 ↗InjuryJan 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN AND DISLOCATION OF THE FEMORAL COMPONENT AND TIBIAL BEARINGS APPROXIMATELY TWO (2) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Joint Dislocation; Pain
MAUDE report 18464278 ↗InjuryAug 4, 2022Migration; Migration
IT WAS REPORTED THAT FOLLOWING RIGHT KNEE ARTHROPLASTY, THE PATIENT IS EXPERIENCING PAIN AND MIGRATION OF THE TIBIAL LOCKING BAR APPROXIMATELY TWO (2) YEARS POST-OPERATIVELY. A REVISION PROCEDURE IS PLANNED AT THIS TIME; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Failure of Implant; Pain
MAUDE report 15165275 ↗InjuryJul 14, 2021Adverse 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: Loss of Range of Motion; Pain; Swelling/ Edema
MAUDE report 12165435 ↗InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema
MAUDE report 12165397 ↗InjuryJul 14, 2021Adverse 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: Loss of Range of Motion; Pain; Swelling/ Edema
MAUDE report 12165387 ↗
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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