Vanguard Knee System EP-189100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304465855), received between Feb 12, 2020 and Feb 12, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Noise, Audible” (1 report).

9 other recalls cover devices cleared under the same FDA submission (K080528, 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. 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.

• InjuryFeb 12, 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 APPROXIMATELY THREE MONTHS POST IMPLANTATION TO HELP WITH RANGE OF MOTION. THE PATIENT ALSO NOTED THAT HE FELT KNEE POPPING WHICH WAS ACCOMPANIED BY PAIN AND SWELLING. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION APPROXIMATELY SIX MONTHS AFTER THE MANIPULATION UNDER ANESTHESIA DUE TO CONTINUED PAIN, RECURRENT RANGE OF MOTION ISSUES, AND PATELLAR SUBLUXATION.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9701802 ↗
• InjuryFeb 12, 2020Noise, Audible; Noise, Audible

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue; Swelling

  MAUDE report 9701798 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080528, K113550, K171054. One submission often covers many models, so check the product and lot details in each record.

• 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-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-0938-2019 · Dec 21, 2018 · Terminated
  Vanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
• Z-0495-2019 · Oct 22, 2018 · Terminated
  Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
• Z-0496-2019 · Oct 22, 2018 · Terminated
  Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
• 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