Vanguard® Knee System 183892Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304440869), received between Dec 30, 2019 and Apr 11, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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.

• MalfunctionApr 11, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE TIBIAL BEARING STERILE PACKAGING WAS FOUND TO HAVE A HOLE IN IT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075431 ↗
• InjuryDec 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE WITH UNKNOWN PRODUCT. DUE TO INFECTION, THE PATIENT UNDERWENT A 2-STAGE REVISION WITH PLACEMENT OF A CEMENT SPACER ON AN UNKNOWN DATE. THE PATIENT LATER UNDERWENT REMOVAL OF THE CEMENT SPACER WITH PLACEMENT OF AN SSK TOTAL KNEE SYSTEM. SUBSEQUENTLY, THE PATIENT UNDERWENT REMOVAL OF THE SSK SYSTEM DUE TO PERSISTENT PAIN AND CHRONIC OVERLOADING OF THE COLLATERAL LIGAMENTS. ALL PRODUCTS WERE REMOVED AND COMPETITOR PRODUCT PLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Damage to Ligament(s); Pain

  MAUDE report 9531973 ↗

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