Vanguard® Knee System 184764Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00887868344084), received between Feb 12, 2020 and Nov 14, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Unstable; Patient-Device Incompatibility; Patient Device Interaction Problem; Unstable; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS EXCESSIVE HYPEREXTENSION APPROXIMATELY ONE (1) YEAR POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Hyperextension

  MAUDE report 23555712 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY FOUR MONTHS LATER THE PATIENT EXPERIENCED A FALL WITH AN UNKNOWN CAUSE AND HAS ONGOING JOINT PAIN. NO FURTHER DETAILS OR OUTCOMES HAVE BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Fall; Pain

  MAUDE report 19370365 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT KNEE MANIPULATION UNDER ANESTHESIA APPROXIMATELY SIX WEEKS POST-IMPLANTATION DUE TO STIFFNESS. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Loss of Range of Motion

  MAUDE report 13479422 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA 10 WEEKS POST IMPLANTATION DUE TO STIFFNESS AND LIMITED EXTENSION. THE OUTCOME WAS REPORTED AS TOLERATED WITH NO FURTHER COMPLICATIONS.

  Patient problems: Adhesion(s); Loss of Range of Motion; Scar Tissue

  MAUDE report 9769596 ↗
• InjuryFeb 28, 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: Loss of Range of Motion; Pain

  MAUDE report 9769357 ↗
• MalfunctionFeb 12, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A PATELLA PREPARED FOR TOTAL KNEE ARTHROPLASTY HAD A FOREIGN SUBSTANCE IN GROOVE ON BACKSIDE OF THE IMPLANT. THE SUBSTANCE WAS REMOVED BY A SMALL NEEDLE AND IT HAS BEEN IMPLANTED IN THE PATIENT BODY. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9699255 ↗

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-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-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-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-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-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-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-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-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-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.