Vanguard® Knee System 183442Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304271142), received between May 11, 2022 and Apr 24, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

20 other recalls cover devices cleared under the same FDA submission (K023546, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2024Material Erosion; Material Erosion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, APPROXIMATELY EIGHT (8) YEARS POST-IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE INSTABILITY AND UNDERWENT REVISION SURGERY DUE TO WEAR OF THE ARTICULAR SURFACE. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS HAVE BEEN MADE; ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 19174150 ↗
• InjurySep 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH A SINGLE CASE STUDY PUBLICATION THAT A PATIENT UNDERWENT A LEFT CRUCIATE-RETAINING TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. APPROXIMATELY 10 MONTHS LATER, THE PATIENT PRESENTED WITH PAIN, TIGHTNESS, AND PERSISTENT SWELLING. INFECTION WAS RULED OUT, AND A BACKED OUT LOCKING BAR WAS IDENTIFIED RADIOGRAPHICALLY, WHICH WAS ALSO PALPABLE SUBCUTANEOUSLY. THE PATIENT UNDERWENT REVISION OF THE POLY BEARING AND LOCKING BAR ON AN UNKNOWN DATE. DURING THE REVISION, THE BEARING WAS DOWNSIZED WHICH PROVIDED A BETTER OVERALL FIT. AT FINAL FOLLOW UP, ALL SYMPTOMS HAD SUBSIDED, AND THE PATIENT REPORTED NO FURTHER COMPLICATIONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15501249 ↗
• InjuryJun 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA FOUR MONTHS POST IMPLANTATION DUE TO RESTRICTED FLEXION RANGE OF MOTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE AT THIS TIME.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 14798997 ↗
• InjuryMay 11, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS INSTABILITY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 14360484 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023546, 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-2150-2020 · Apr 17, 2020 · Terminated
  Knee Products: 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM 189048 Vanguard Knee System, AS Tibia
• Z-2153-2020 · Apr 17, 2020 · Terminated
  Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vang
• 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
• Z-0673-2018 · Sep 29, 2017 · Terminated
  Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 Product Usage: For use in total knee arthroplasty
• Z-0674-2018 · Sep 29, 2017 · Terminated
  Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540 Product Usage: For use in total knee arthroplasty
• Z-1115-2017 · Jan 4, 2017 · Terminated
  Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM
• Z-0111-2017 · Aug 9, 2016 · Terminated
  Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage: Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or

…and 5 more.