VANGUARD UNIVERSAL 5-IN-1 TIBIAL 32-483840Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00880304443730), received between Apr 5, 2021 and Dec 10, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 reports).

7 other recalls cover devices cleared under the same FDA submission (K113550); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768463 ↗
• MalfunctionAug 2, 2023Fracture; Fracture

  IT WAS REPORTED THE POLY TRIALS WERE FRACTURED DURING THE PROCEDURE. THERE IS NO KNOWN PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17445791 ↗
• MalfunctionMar 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INITIAL KNEE SURGERY, THE SURGEON BROKE THE POLY TRIAL. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO SURGICAL DELAY. NO FOREIGN BODIES WERE RETAINED. THE SURGERY WAS COMPLETED WITH A SECOND DEVICE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16636934 ↗
• InjuryDec 6, 2022Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15923401 ↗
• MalfunctionAug 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE TRIAL BROKE DURING SURGERY. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15248791 ↗
• MalfunctionApr 5, 2021Fracture; Fracture

  IT WAS REPORTED THE TIBIAL TRIAL WAS DISCOVERED FRACTURED DURING SURGERY. NO PRODUCT FELL INTO THE PATIENT. THE SURGICAL TECHNIQUE WAS UTILIZED. THERE WAS NO PATIENT IMPACT. THERE WAS NO SURGICAL DELAY. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612822 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113550. 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-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-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