Vanguard® Knee System 183868Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304440838), received between Mar 3, 2022 and Sep 20, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Off-Label Use” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K042757, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 17783045 ↗
• MalfunctionMar 3, 2022Positioning Failure; Off-Label Use; Positioning Failure; Off-Label Use

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY, THE BEARING WOULD NOT MATE WITH CORRESPONDING FEMUR IMPLANT. IT WAS BELIEVED THAT THIS DEVICE WAS COMPATIBLE WITH THE CORRESPONDING IMPLANTS. WHEN THE SURGEON COULD NOT GET A PROPER FIT, THEY SAWED OFF PART OF THE POST ON THIS DEVICE TO ADJUST THE FIT. THERE WAS A SURGICAL DELAY OF 30 MINUTES AND IT'S BEEN REPORTED THAT THE PATIENT IS WAITING FOR THE CORRECT IMPLANT, INDICATING A REVISION IS LIKELY TO OCCUR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659372 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042757, 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-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