Vanguard Knee SystemRecalls & reported problems across all models
Biomet Orthopedics, LLC · 147 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one Vanguard Knee System model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 306
- Deaths reported
- 0
- Injuries reported
- 243
- Recalls
- 13
We found 147 models of Vanguard Knee System by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 306 adverse event reports in the FDA's MAUDE database, received between Sep 10, 2019 and Aug 17, 2026 — classified as 243 injuries, 63 malfunctions.
The most frequently reported specific device problem is “Unstable” (36 reports).
13 FDA recall records name at least one of these models by its device identifier, 3 still open.
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 Knee 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.
- Mar 13, 2024Open, Classified
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
Z-1607-2024 · Root cause: Process change control · Recall details · FDA record ↗
- Dec 29, 2022Open, Classified
Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
Z-1043-2023 · Root cause: Labeling Change Control · names 3 of these models · Recall details · FDA record ↗
- Dec 29, 2022Open, Classified
Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).
Z-1042-2023 · Root cause: Labeling Change Control · names 4 of these models · Recall details · FDA record ↗
- Apr 17, 2020Terminated
Potential presence of elevated endotoxin levels that exceed the specification limit
Z-2154-2020 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗
- Apr 17, 2020Terminated
Potential presence of elevated endotoxin levels that exceed the specification limit
Z-2153-2020 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗
- Apr 17, 2020Terminated
Potential presence of elevated endotoxin levels that exceed the specification limit
Z-2152-2020 · Root cause: Process control · names 6 of these models · Recall details · FDA record ↗
- Apr 17, 2020Terminated
Potential presence of elevated endotoxin levels that exceed the specification limit
Z-2151-2020 · Root cause: Process control · names 5 of these models · Recall details · FDA record ↗
- Apr 17, 2020Terminated
Potential presence of elevated endotoxin levels that exceed the specification limit
Z-2150-2020 · Root cause: Process control · names 4 of these models · Recall details · FDA record ↗
- Dec 21, 2018Terminated
Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
Z-0938-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Dec 21, 2018Terminated
Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
Z-0937-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Oct 22, 2018Terminated
Label on the outer carton or the patient labels does not match label on the inner sterile packaging
Z-0496-2019 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
- Oct 22, 2018Terminated
Label on the outer carton or the patient labels does not match label on the inner sterile packaging
Z-0495-2019 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
- May 11, 2018Terminated
The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
Z-2183-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Vanguard Knee System problems
Device problems
- Adverse Event Without Identified Device or Use Problem129
- Unstable36
- Packaging Problem30
- Loosening of Implant Not Related to Bone-Ingrowth24
- Tear, Rip or Hole in Device Packaging24
- Insufficient Device Problem Information17
- Naturally Worn15
- Noise, Audible12
Patient problems
- Pain128
- Loss of Range of Motion75
- No Clinical Signs, Symptoms or Conditions60
- Failure of Implant34
- Ambulation or Postural Difficulties33
- Swelling/ Edema33
- Joint Laxity31
- Scar Tissue31
Vanguard Knee System models
147 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- VANGUARD KNEE SYSTEM 184764PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 recalls5 reports
- Vanguard® Knee System 183108PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 recalls3 reports
- Vanguard® Knee System 183126PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 recalls3 reports
- Vanguard® Knee System 189082PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 recalls2 reports
- Vanguard® Knee System 183620PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall5 reports
- Vanguard® Knee System 183106PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall4 reports
- Vanguard® Knee System 183104PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall3 reports
- Vanguard® Knee System 183122PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall3 reports
- VANGUARD KNEE SYSTEM 184762PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall3 reports
- VANGUARD KNEE SYSTEM 184766PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall3 reports
- Vanguard® Knee System 183124PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall2 reports
- Vanguard® Knee System 183622PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall1 report
- Vanguard® Knee System 183742PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall1 report
- Vanguard Knee System 189260PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall1 report
- Vanguard® Knee System 183112PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Vanguard® Knee System 189048PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall0 reports
- Vanguard® Knee System 183744PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Vanguard Knee System 189320Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall0 reports
- Vanguard Knee System 189440Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall0 reports
- Vanguard Knee System 189460PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- Vanguard Knee System 189442PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Vanguard Knee System 189422PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Vanguard Knee System 189420Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall0 reports
- Vanguard Knee System 189426PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Vanguard Knee System EP-183608Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall0 reports
- Vanguard Knee System 189700PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Vanguard Knee System 189704Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall0 reports
- Vanguard Knee System 189720Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall0 reports
- VANGUARD KNEE SYSTEM 183621Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall0 reports
- VANGUARD KNEE SYSTEM 183099PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER29 reports
- Vanguard® Knee System 183420PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- Vanguard® Knee System 183008PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- VANGUARD® KNEE SYSTEM 183099PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- Vanguard® Knee System 184764Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive6 reports
- Vanguard® Knee System 183004PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- Vanguard® Knee System 183006PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- Vanguard® Knee System 183012PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- Vanguard® Knee System 183440PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- Vanguard® Knee System 183640PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- VANGUARD KNEE SYSTEM 184768PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- Vanguard® Knee System 183033PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- Vanguard Knee System EP-183620PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- Vanguard® Knee System 183028PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- Vanguard® Knee System 183032PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- Vanguard® Knee System 183422PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- Vanguard® Knee System 183442PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- Vanguard® Knee System 189120PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER4 reports
- Vanguard® Knee System 189062PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER4 reports
- Vanguard Knee System EP-183640PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- Vanguard® Knee System 184788Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive4 reports
- Vanguard® Knee System 183014PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Vanguard® Knee System 183034PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Vanguard® Knee System 183050PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- Vanguard® Knee System 183132PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- VANGUARD KNEE SYSTEM 184786PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Vanguard® Knee System 189042PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- Vanguard Knee System EP-183642Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer3 reports
- Vanguard® Knee System 183010PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Knee System 183024PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Knee System 183026PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Knee System 183030PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Knee System 183110PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Knee System 183130PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Knee System 183424PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Knee System 183460PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Knee System 183642PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Knee System 183660PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Knee System 183682PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- VANGUARD KNEE SYSTEM 184784PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- VANGUARD KNEE SYSTEM 184704PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Knee System 189040PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Knee System 189100PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Knee System 189104PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Vanguard® Knee System 183886PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Knee System 183868PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Knee System 183892PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Knee System 183013PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard Knee System EP-189100PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- Vanguard Knee System CP113616Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive2 reports
- Vanguard Knee System CP113642Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive2 reports
- Vanguard® Knee System 184766Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive2 reports
- Vanguard® Knee System 184784PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Vanguard® Knee System 183036PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Vanguard® Knee System 183044PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Vanguard® Knee System 183046PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Vanguard® Knee System 183048PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Vanguard® Knee System 183054PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Vanguard® Knee System 183064PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Vanguard® Knee System 183066PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Vanguard® Knee System 183128Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 report
- Vanguard® Knee System 183426PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Vanguard® Knee System 183444PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Vanguard® Knee System 183624PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Vanguard® Knee System 183630PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Vanguard® Knee System 183664PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Vanguard® Knee System 183666PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Vanguard® Knee System 183680PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- VANGUARD KNEE SYSTEM 184788PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Vanguard® Knee System 189024PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Vanguard® Knee System 189090PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
Recent Vanguard Knee System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent a right total knee arthroplasty. Subsequently, the patient underwent an additional procedure approximately 1 year post-op to realign and adjust the kneecap due to ongoing swelling, nerve pain, inflammation, and scar tissue with restricted range of motion. No devices were revised. Attempts have been made and all available information has been provided.
Patient problems: Inflammation; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema
MAUDE report 50278278 ↗InjuryAug 3, 2026Loosening of Implant Not Related to Bone-Ingrowth
It was reported that the patient underwent a right total knee arthroplasty and was subsequently revised approximately 18 months post-implantation due to pain, instability, and aseptic loosening. It was reported that no further information is available.
Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema
MAUDE report 50120648 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient had a right total knee arthroplasty. Subsequently, the patient underwent a superficial irrigation and debridement procedure approximately 5 weeks post-op due to persistent wound drainage and superficial wound infection cellulitis. No product was exchanged. Intra-op cultures were positive for MRSA. The infection resolved after the procedure and oral antibiotics. Attempts have been made and all available information has been provided.
Patient problems: Abscess; Bacterial Infection; Cellulitis; Fluid Discharge; Post Operative Wound Infection
MAUDE report 50038392 ↗InjuryJul 17, 2026Fracture
IT WAS REPORTED PATIENT UNDERWENT AN INITIAL LEFT KNEE SURGERY. APPROXIMATELY 1.3 YEARS POST-IMPLANTATION THE PATIENT UNDERWENT A REVISION DUE TO A BROKEN ARTICULAR SURFACE. THE PATIENT DID NOT REPORT A PRECIPITATING EVENT SUCH AS A FALL, STATING THE ISSUE OCCURRED SPONTANEOUSLY. THE PATIENT EXPERIENCED PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Pain
MAUDE report 25853002 ↗InjuryJun 15, 2026Fracture
IT WAS REPORTED THE PATIENT UNDERWENT A TOTAL KNEE REVISION DUE TO INSTABILITY. DURING THE PROCEDURE, THE POSTERIOR-STABILIZED POST WAS FOUND BROKEN OFF THE POLYETHYLENE INSERT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Laxity
MAUDE report 25511376 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Extraskeletal ossification
MAUDE report 25172476 ↗InjuryApr 21, 2026Naturally Worn
IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED INSTABILITY, PATELLOFEMORAL PAIN, SUBLUXATION FROM EXTENDED TO FLEXED POSITION, PATELLOFEMORAL SUBLUXATION, AND CREPITUS. APPROXIMATELY, 10.6 YEARS POST-OP UNDERWENT A REVISION WHERE THE ARTICULAR SURFACE WAS WORN AND THE PATELLA WAS RESURFACED. THE ARTICULAR SURFACE WAS REVISED, AND ALL OTHER IMPLANTS WERE RETAINED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Crepitus; Implant Pain; Joint Laxity; Pain; Subluxation
MAUDE report 24940841 ↗InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Arthrofibrosis; Crepitus; Loss of Range of Motion; Pain; Swelling/ Edema
MAUDE report 24699193 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO PAIN, ARTHROFIBROSIS, AND ANKYLOSIS. SUBSEQUENTLY, THE PATIENT CONTINUES TO REPORT UNRESOLVED EXTREME PAIN TO LEFT KNEE, AND NO ADDITIONAL INTERVENTIONS HAVE BEEN PERFORMED. PATIENT STATED THE BONE CEMENT THAT WAS USED WITH HER IMPLANTS WAS RECALLED DUE TO BEING TOXIC. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Patient problems: Ankylosis; Arthrofibrosis; Pain
MAUDE report 24640530 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE MONTH FOLLOWING A LEFT TOTAL KNEE ARTHROPLASTY WAS PERFORMED, A PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT OF LEFT LEG DVT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Patient problems: Thromboembolism
MAUDE report 24640504 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE MONTH FOLLOWING A LEFT TOTAL KNEE ARTHROPLASTY WAS PERFORMED, A PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT OF LEFT LEG DVT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Patient problems: Thromboembolism
MAUDE report 24640413 ↗InjuryMar 18, 2026Naturally Worn
IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO PAIN AND SUSPECTED POLY WEAR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Patient problems: Pain; Swelling/ Edema
MAUDE report 24634719 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Joint Laxity; Loss of Range of Motion; Muscle/Tendon Damage; Pain; Swelling/ Edema
MAUDE report 24498410 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Joint Laxity; Loss of Range of Motion; Muscle/Tendon Damage; Pain; Swelling/ Edema
MAUDE report 24498408 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Joint Laxity; Loss of Range of Motion; Muscle/Tendon Damage; Pain; Swelling/ Edema
MAUDE report 24498396 ↗
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
- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 recalls
- Comprehensive Shoulder System68 models · 191 reports · 11 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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