Vanguard Vivacit-ERecalls & reported problems across all models
Zimmer, Inc. · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 26
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 17 models of Vanguard Vivacit-E by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Nov 25, 2020 and Sep 23, 2026 — classified as 12 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (4 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 Vivacit-E problems
Device problems
- Adverse Event Without Identified Device or Use Problem6
- Difficult to Insert4
- Packaging Problem4
- Positioning Failure4
- Unstable3
- Tear, Rip or Hole in Device Packaging2
- Material Deformation1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Pain6
- Joint Laxity4
- Muscle Weakness/Atrophy3
- Swelling/ Edema3
- Ambulation or Postural Difficulties2
- Failure of Implant2
- Fall2
Vanguard Vivacit-E models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Vanguard® Vivacit-E® VE189064PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Vanguard® Vivacit-E® VE189100Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive3 reports
- Vanguard® Vivacit-E® VE189040PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Vivacit-E® VE183440PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Vivacit-E® VE183620PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Vivacit-E® VE183640PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Vivacit-E® VE183661PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Vanguard® Vivacit-E® VE189061PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Vanguard® Vivacit-E® VE189066PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Vanguard® Vivacit-E® VE189088Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 report
- Vanguard® Vivacit-E® VE189102PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Vanguard® Vivacit-E® VE183420PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Vanguard® Vivacit-E® VE183442Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 report
- Vanguard® Vivacit-E® VE183460PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- Vanguard® Vivacit-E® VE183560PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Vanguard® Vivacit-E® VE183641PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Vanguard® Vivacit-E® VE183642Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 report
Recent Vanguard Vivacit-E 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 50867966 ↗MalfunctionFeb 12, 2026Difficult to Insert
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321786 ↗MalfunctionDec 4, 2025Positioning Failure; Positioning Failure
IT WAS REPORTED THAT AFTER INSTALLING THE BEARING, THE LOCKING BAR DIDN'T GO STRAIGHT IN AND COULD NOT BE SEATED IN THE TIBIAL TRAY. STAFF NOTICED THAT THE BOTTOM SURFACE OF THE BEARING WAS NOT FLAT AND IT TILTED LIKE A SEESAW WHEN PLACED ON THE TIBIAL TRAY. THE SURGERY WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS LESS THAN A 30 MINUTE DELAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23715983 ↗MalfunctionNov 25, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING FINAL TESTING OF THE FINAL BEARING IMPLANT, THE SURGEON DETERMINED THAT THE KNEE WAS UNSTABLE, HOWEVER, THE KNEE FELT STABLE DURING TRIALING. THE SURGEON REMOVED THE FINAL BEARING AND NOTICED THAT THE POSTERIOR LIP HAD DAMAGED THAT APPEARED TO BE MELTING OR DISFIGURED. THE SURGEON USED A NEW BEARING TO COMPLETE THE SURGERY ENSURING KNEE STABILITY. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23645052 ↗InjuryNov 13, 2025Adverse 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: Ambulation or Postural Difficulties; Ankylosis; Arthrofibrosis; Cyst(s); Loss of Range of Motion; Nerve Damage; Neuropathy; Pain; Swelling/ Edema
MAUDE report 23548838 ↗MalfunctionOct 15, 2025Positioning Failure; Positioning Failure
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23302390 ↗InjuryAug 28, 2025Adverse 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: Joint Laxity; Muscle Weakness/Atrophy; Pain; Swelling/ Edema
MAUDE report 22911571 ↗MalfunctionJun 30, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING FINAL TESTING OF THE FINAL BEARING IMPLANT, THE SURGEON DETERMINED THAT THE KNEE WAS UNSTABLE, HOWEVER, THE KNEE FELT STABLE DURING TRIALING. THE SURGEON REMOVED THE FINAL BEARING AND NOTICED THAT THE POSTERIOR LIP HAD DAMAGED THAT APPEARED TO BE MELTING OR DISFIGURED. THE SURGEON USED A NEW BEARING TO COMPLETE THE SURGERY ENSURING KNEE STABILITY. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22357476 ↗MalfunctionJan 2, 2025Packaging Problem; Packaging Problem
IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT UPON OPENING UP THE ARTICULAR SURFACE IMPLANT, THE DEVICE WAS IDENTIFIED TO HAVE A HAIR ON IT WITHIN THE PACKAGING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21055955 ↗MalfunctionDec 27, 2024Packaging Problem; Packaging Problem
IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT THE SURGEON IDENTIFIED A FIBROUS FOREIGN SUBSTANCE ON THE TIBIAL BEARING DURING INSERTION. THE IMPLANT WAS STILL USED TO COMPLETE THE PROCEDURE AFTER THE SUBSTANCE WAS REMOVED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21027079 ↗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 20684607 ↗MalfunctionNov 6, 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 20622212 ↗InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ONE (1) YEAR AND SEVEN (7) MONTHS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE INSTABILITY. A REVISION SURGERY WAS PERFORMED AND THE ARTICULAR SURFACE WAS EXCHANGED WITHOUT REPORTED COMPLICATION. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Joint Laxity
MAUDE report 20136266 ↗InjuryJul 15, 2024Migration; Migration
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19741263 ↗InjuryJul 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO YEARS AND FOUR MONTHS POST IMPLANTATION DUE TO PAIN, INSTABILITY, EFFUSIONS, AND PATELLA IMPINGEMENT WITH MALALIGNMENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.
Patient problems: Joint effusion; Muscle Weakness/Atrophy; Pain; Swelling/ Edema
MAUDE report 19710601 ↗
Other Zimmer, Inc. products
- PERSONA364 models · 2,000 reports · 3 recalls
- Persona The Personalized Knee77 models · 1,396 reports
- PERSONA Vivacit-E285 models · 1,152 reports
- NexGen198 models · 842 reports · 4 recalls
- Affixus18 models · 1 reports · 17 recalls
- PERSONA Natural Tibia25 models · 417 reports · 2 recalls
- NexGen Legacy119 models · 319 reports · 3 recalls
- Alliance32 models · 275 reports · 2 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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