VANGUARD KNEE SYSTEM 184766Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304434349), received between Oct 1, 2019 and Jul 21, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Noise, Audible” (2 reports).

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. Dec 21, 2018Terminated

   Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.

   Z-0938-2019 · Root cause: Under Investigation by firm · 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.

• InjuryJul 21, 2022Noise, Audible; Noise, Audible

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN, INSTABILITY AND POPPING IN KNEE APPROXIMATELY 3 YEARS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Discomfort; Pain

  MAUDE report 15074380 ↗
• InjuryApr 20, 2021Adverse 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: Necrosis; Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 11693779 ↗
• InjuryOct 1, 2019Unstable; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT APPROXIMATELY 6 MONTHS POST IMPLANTATION OF A RIGHT TKA, THE PATIENT WAS SUFFERING FROM WEAKNESS, STIFFNESS, GAIT DEVIATION, AND PAIN. THE PATIENT WAS ALSO FURTHER EXPERIENCING PARESTHESIA, BURNING, PINS AND NEEDLES SENSATION, AND INSTABILITY IN THE AFFECTED LEG. IT IS UNKNOWN IF THE PATIENT HAS HAD ANY INTERVENTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Burning Sensation; Limited Mobility Of The Implanted Joint; Pain; Swelling; Tingling

  MAUDE report 9139201 ↗

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-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-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-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-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-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-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
• 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

…and 1 more.