Vanguard® Knee System 183420Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00880304271050), received between Apr 21, 2021 and Apr 21, 2026 — classified as 12 injuries.

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

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Naturally Worn

  IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT DEVELOPED INSTABILITY, PATELLOFEMORAL PAIN, SUBLUXATION FROM EXTENDED TO FLEXED POSITION, PATELLOFEMORAL SUBLUXATION, AND CREPITUS. APPROXIMATELY, 10.6 YEARS POST-OP UNDERWENT A REVISION WHERE THE ARTICULAR SURFACE WAS WORN AND THE PATELLA WAS RESURFACED. THE ARTICULAR SURFACE WAS REVISED, AND ALL OTHER IMPLANTS WERE RETAINED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Crepitus; Implant Pain; Joint Laxity; Pain; Subluxation

  MAUDE report 24940841 ↗
• InjuryMar 18, 2026Naturally Worn

  IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO PAIN AND SUSPECTED POLY WEAR. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 24634719 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY SEVEN YEARS SEVEN AND A HALF MONTHS POST IMPLANTATION DUE TO COLLAPSE OF THE IMPLANT ON ONE SIDE CAUSING PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 23933807 ↗
• InjuryDec 5, 2025Degraded; Naturally Worn; Degraded; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY REVISION TO ADDRESS POLYETHYLENE WEAR AND TIBIAL SUBSIDENCE ACCOMPANIED BY PAIN APPROXIMATELY ELEVEN (11) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 23727024 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 20878967 ↗
• InjuryDec 2, 2024Naturally Worn; Naturally Worn

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

  Patient problems: Failure of Implant

  MAUDE report 20818798 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY THREE YEARS POST-IMPLANTATION DUE TO PAIN, SWELLING, AND INSTABILITY THAT INTERFERED WITH DAILY LIVING AND CAUSED THE PATIENT TO RELY ON AMBULATORY AIDS. DURING THE REVISION, THE CRUCIATE-RETAINING 10MM TIBIAL INSERT WAS REMOVED AND REPLACED WITH AN ANTERIOR-STABILIZING 14MM TIBIAL INSERT. NO FURTHER ISSUES HAVE BEEN REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Fall; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 20050877 ↗
• InjuryNov 20, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION OF THE TIBIAL BEARING AND RESURFACED THE PATELLA TO ADDRESS PAIN AND PATELLAR OSTEOARTHRITIS APPROXIMATELY EIGHT (8) YEARS POST-OPERATIVELY. UPON REMOVAL, MINIMAL WEAR WAS IDENTIFIED ON THE TIBIAL BEARING. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 18169753 ↗
• InjuryNov 3, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THE PATIENT UNDERWENT A LEFT KNEE REVISION OF THE POLY WHICH WAS NOTED TO HAVE SOME WEAR MEDIALLY AND HAD PATELLAR RESURFACING DUE TO DEGENERATIVE JOINT DISEASE. ATTEMPTS HAVE BEEN MADE, BUT THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

  Patient problems: Pain

  MAUDE report 12746098 ↗
• InjuryJul 19, 2021Unstable; Unstable

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

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion

  MAUDE report 12191972 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A BILATERAL KNEE PROCEDURE APPROXIMATELY 28 MONTHS AGO. SUBSEQUENTLY, THE PATIENT HAS EXPERIENCED ISSUES WITH THE RIGHT KNEE. THE PATIENT STATES SHE IS HAVING BUCKLING OF THE KNEE WHEN WALKING. SHE IS ALSO EXPERIENCING HER KNEE LOCKING UP AND HER KNEE FEELING SHAKY. SHE STATED THAT AT NIGHT, THE KNEE LOCKS UP SO BADLY THAT HER HUSBAND HAS TO PULL ON THE KNEE TO MOVE IT INTO THE CORRECT POSITION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion

  MAUDE report 12122017 ↗
• InjuryApr 21, 2021Unstable; Loosening of Implant Not Related to Bone-Ingrowth; Unstable; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Joint Laxity; Pain; Scar Tissue

  MAUDE report 11699309 ↗

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-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-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-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-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-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-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.