Vanguard® Knee System 189082Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304436954), received between Dec 2, 2021 and Jun 12, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 FDA recall records name this device's identifier, 1 still open.

9 other recalls cover devices cleared under the same FDA submission (K050222, K113550, 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 13, 2024Open, Classified

   Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.

   Z-1607-2024 · Root cause: Process change control · FDA record ↗

2. Apr 17, 2020Terminated

   Potential presence of elevated endotoxin levels that exceed the specification limit

   Z-2150-2020 · Root cause: Process control · FDA record ↗

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.

• InjuryJun 12, 2025Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION OF THE TIBIAL BEARING TO ADDRESS UNKNOWN COMPLICATIONS APPROXIMATELY FIFTEEN (15) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Pain; Synovitis

  MAUDE report 22193240 ↗
• InjuryDec 2, 2021Unstable; Unstable

  IT WAS REPORTED THAT UNSTABLE KNEE WITH TIBIAL COMPONENTS SHOWED INCREASED HOT SPOTS IN SCAN ACCORDING TO THE SURGEON. REVISION SURGERY DUE TO UNSTABLE KNEE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 12916700 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050222, K113550, K171054. One submission often covers many models, so check the product and lot details in each record.

• Z-1042-2023 · Dec 29, 2022 · Open, Classified
  (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right
• Z-1043-2023 · Dec 29, 2022 · Open, Classified
  (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED RECALL: (2) Vanguard Knee System PS Ope
• Z-0938-2019 · Dec 21, 2018 · Terminated
  Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
• Z-0496-2019 · Oct 22, 2018 · Terminated
  Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
• Z-0495-2019 · Oct 22, 2018 · Terminated
  Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
• 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-1011-2018 · Oct 3, 2017 · Terminated
  Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplasty