Vanguard® Knee System 183006Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00880304270398), received between Mar 8, 2022 and Dec 31, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 23933798 ↗
• InjuryAug 28, 2025Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Aseptic loosening; Joint Laxity; Muscle Weakness/Atrophy; Pain; Swelling/ Edema

  MAUDE report 22913557 ↗
• InjuryJul 21, 2022Unstable; Noise, Audible; Unstable; Noise, Audible

  IT WAS REPORTED PATIENT IS EXPERIENCING PAIN, INSTABILITY AND POPPING IN KNEE APPROXIMATELY 3 YEARS POST IMPLANTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Discomfort; Pain

  MAUDE report 15074333 ↗
• 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 14798995 ↗
• InjuryMar 8, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE ARTHROPLASTY. APPROXIMATELY 13 MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO PAIN AND LOOSENING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 13695474 ↗

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-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-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-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.