VANGUARD KNEE SYSTEM 184762Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304431638), received between Jan 6, 2020 and Oct 10, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

1 FDA recall record name this device's identifier.

16 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.

Recalls naming this device

1. Apr 17, 2020Terminated

   Potential presence of elevated endotoxin levels that exceed the specification limit

   Z-2154-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2024Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Failure of Implant

  MAUDE report 20415827 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AND STIFFNESS AND SUBSEQUENTLY UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY SIX MONTHS POST LEFT KNEE ARTHROPLASTY DUE TO ARTHROFIBROSIS.

  Patient problems: Adhesion(s); Fibrosis; Loss of Range of Motion; Pain

  MAUDE report 9752263 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS EXPERIENCING PAIN AND STIFFNESS AND SUBSEQUENTLY UNDERWENT A MANIPULATION UNDER ANESTHESIA APPROXIMATELY SIX MONTHS POST RIGHT KNEE ARTHROPLASTY DUE TO ARTHROFIBROSIS.

  Patient problems: Fibrosis; Loss of Range of Motion; Pain

  MAUDE report 9554482 ↗

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-0938-2019 · Dec 21, 2018 · Terminated
  Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
• Z-0937-2019 · Dec 21, 2018 · Terminated
  Vanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
• 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-0698-2012 · 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 patellofe
• 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-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-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-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-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-0697-2012 · Oct 4, 2011 · Terminated
  Biomet Series A Standard Patella size 28mm, one peg - 184702, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & ACG Knee system. Knee joint patellofemo
• 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

…and 1 more.