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VANGUARD COMPLETE KNEE SYSTEM 195919Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

All models of Vanguard Complete Knee System (27)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304560437), received between Jan 8, 2024 and Jan 8, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K141407); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 2 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Device Dislodged or Dislocated2

Patient problems

  • Joint Dislocation2
  • Pain2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • 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 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K141407. One submission often covers many models, so check the product and lot details in each record.

  • Z-1265-2016 · Feb 5, 2016 · Terminated
    Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncement

Other Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices

All Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices →

Sources and updates

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