VANGUARD KNEE SYSTEM 184768Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304436633), received between Jan 8, 2020 and Jan 12, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

17 other recalls cover devices cleared under the same FDA submission (K040770, K171054); 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE THREE YEARS POST IMPLANTATION DUE TO PAINFUL PATELLA AND FEMORAL LOOSENING. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Failure of Implant; Pain

  MAUDE report 13235368 ↗
• InjuryApr 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 11716097 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT IS EXPERIENCING KNEE PAIN FOUR AND HALF YEARS POST IMPLANTATION. NO REVISION PROCEDURE HAS BEEN REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 10200598 ↗
• InjuryApr 6, 2020Adverse 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: Bacterial Infection; Scar Tissue

  MAUDE report 9928120 ↗
• InjuryJan 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED THAT APPROXIMATELY 5 MONTHS POST L KNEE IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE PAIN TO HIS LEFT EXTREMITY AND WAS FOUND TO HAVE A DVT. THE PATIENT CONTINUED TO SUFFER FROM FURTHER DVTS AND PE, AND EVENTUALLY DEVELOPED A HEMATOMA RELATED TO BLOOD THINNER TREATMENT FROM THE DVTS. PATIENT HAS CONTINUED TO HAVE THESE ISSUES, APPROXIMATELY 2.5 YEARS POST IMPLANTATION. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE AND NONE HAS BEEN PROVIDED.

  Patient problems: Edema; Hematoma; Numbness; Pain; Pulmonary Embolism; Swelling; Thrombosis

  MAUDE report 9563400 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040770, K171054. One submission often covers many models, so check the product and lot details in each record.

• Z-2154-2020 · Apr 17, 2020 · Terminated
  Knee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosth
• Z-0937-2019 · Dec 21, 2018 · Terminated
  Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
• Z-0938-2019 · Dec 21, 2018 · Terminated
  Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
• Z-2289-2018 · May 24, 2018 · Terminated
  Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthropla
• Z-2177-2018 · May 18, 2018 · Terminated
  Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total
• Z-2183-2018 · May 11, 2018 · Terminated
  Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
• Z-1861-2017 · Feb 17, 2017 · Terminated
  various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Pa
• Z-0703-2012 · Oct 4, 2011 · Terminated
  Biomet Series A Asymmetrical Patella size 25mm, three pegs - 184790, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee. J
• Z-0696-2012 · Oct 4, 2011 · Terminated
  Biomet Series A Standard Patella size 25mm, one peg, Part 184700, Sterile, Biomet Orthopedics, Warsaw, IN 46582 Knee joint patellofemorotibial, cemented, polymer/metal/polymer, se
• Z-0704-2012 · Oct 4, 2011 · Terminated
  Biomet Series A Asymmetrical Patella size 28mm, three pegs - 184791, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee. J
• Z-0700-2012 · Oct 4, 2011 · Terminated
  Biomet Series A Standard Patella size 25mm, three pegs - 184760, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint p
• Z-0699-2012 · Oct 4, 2011 · Terminated
  Biomet Series A Thin Patella size 25mm, one peg - 184720, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellof
• Z-0701-2012 · Oct 4, 2011 · Terminated
  Biomet Series A Standard Patella size 28mm, three pegs - 184762, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint p
• Z-0702-2012 · Oct 4, 2011 · Terminated
  Biomet Series A Thin Patella size 28mm, three pegs - 184782, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patel
• Z-0695-2012 · Oct 4, 2011 · Terminated
  Biomet Series A Thin Patella size 25mm, three pegs, Part 184780, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems. Knee join

…and 2 more.