Vanguard Knee System EP-183640Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304465749), received between Apr 21, 2022 and Mar 19, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Unstable” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT MANIPULATION UNDER ANESTHESIA APPROXIMATELY TWO MONTHS POST IMPLANTATION DUE TO PAIN, ARTHROFIBROSIS, AND ANKYLOSIS. SUBSEQUENTLY, THE PATIENT CONTINUES TO REPORT UNRESOLVED EXTREME PAIN TO LEFT KNEE, AND NO ADDITIONAL INTERVENTIONS HAVE BEEN PERFORMED. PATIENT STATED THE BONE CEMENT THAT WAS USED WITH HER IMPLANTS WAS RECALLED DUE TO BEING TOXIC. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Ankylosis; Arthrofibrosis; Pain

  MAUDE report 24640530 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MONTH FOLLOWING A LEFT TOTAL KNEE ARTHROPLASTY WAS PERFORMED, A PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT OF LEFT LEG DVT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Thromboembolism

  MAUDE report 24640504 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN, INSTABILITY, LOSS OF RANGE OF MOTION AND LOOSENING OF FEMORAL AND TIBIAL COMPONENTS APPROXIMATELY TWO (2) YEARS POST-OPERATIVELY. ALL COMPONENTS WERE REVISED. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 21675722 ↗
• InjuryApr 21, 2022Unstable; Unstable

  IT WAS REPORTED VIA A CLINICAL STUDY THAT A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, TEN MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN, STIFFNESS, SWELLING, CLICKING, AND INSTABILITY. A CT SCAN PRIOR TO THE REVISION NOTED THAT THE TIBIAL COMPONENT HAD INTERNALLY ROTATED. DURING THE PROCEDURE, THE SURGEON FOUND THAT THERE WAS CEMENT PRESENT ON THE BONE AND TIBIAL IMPLANT, WHICH WAS EASILY REMOVED. THE FEMORAL IMPLANT HAD NO CEMENT ATTACHED. THE PATELLAR COMPONENT WAS LEFT INTACT BUT ALL OTHER COMPONENTS WERE REVISED WITHOUT COMPLICATION.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 14166364 ↗

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-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-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