Vanguard® Knee System 189120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304436992), received between Mar 25, 2022 and Mar 26, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

10 other recalls cover devices cleared under the same FDA submission (K050222, 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.

• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

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

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

  MAUDE report 24699193 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Ambulation or Postural Difficulties; Extraskeletal ossification; Joint Laxity; Loss of Range of Motion; Muscle/Tendon Damage; Pain; Swelling/ Edema

  MAUDE report 24498396 ↗
• InjuryJan 20, 2026Malposition of Device; Insufficient Device Problem Information; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT HAS BEEN RECOMMENDED TO UNDERGO A RIGHT KNEE ARTHROPLASTY REVISION APPROXIMATELY THREE (3) MONTHS POST-OPERATIVELY TO ADDRESS CONTINUED INSTABILITY, SEVERE VARUS DEFORMITY, TIBIAL COMPONENT SUBLUXATION, LIMITED FLEXION AND CREPITUS. THE PATIENT HAS UNDERGONE PHYSIOTHERAPY, MAGNETIC THERAPY, LASER THERAPY, MASSAGE AND UTILIZES A KNEE BRACE AND CANE FOR WALKING. INITIAL OPERATIVE NOTES NOTED NO INTRAOPERATIVE COMPLICATIONS. HOWEVER, THE PATIENT'S DISCHARGE SUMMARY NOTED THAT THE PATIENT'S KNEE JOINT WAS DEFORMED AND DEFLECTED WITH SEVERE VARUS DEFORMITY OF THE LOWER EXTREMITY NOTED. THE PATIENT WAS NOTED TO HAVE PRESERVED ACTIVE KNEE MOTION, BUT WAS SIGNIFICANTLY LIMITED WITH MODERATE HYPOTROPHY OF THE THIGH, A PRONOUNCED CRUNCHING SOUND WITH MOVEMENT AND PAIN. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Crepitus; Deformity/ Disfigurement; Fall; Insufficient Information; Joint Laxity; Subluxation; Unequal Limb Length

  MAUDE report 24118843 ↗
• InjuryMar 25, 2022Unstable; Unstable

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS AFTER PRIMARY TKA, PATIENT DEVELOPED AN UNSTABLE LEFT KNEE. FOLLOWING CONSERVATIVE TREATMENT, THE SURGEON ELECTED TO REVISE THE KNEE. NO OBVIOUS PROBLEMS COULD BE FOUND, EXCEPT FOR THE INSTABILITY. NO INFECTION OR SYNOVIAL INFLAMMATION, NO OBVIOUS LIGAMENTOUS DAMAGE, ALL COMPONENTS WERE WELL FIXED. THE LOCKING PIN AND 10X83 AS BEARING WAS REMOVED AND SHOWED NO SIGNS OF WEAR. A 14X83 AS BEARING AND NEW LOCKING PIN WAS IMPLANTED. KNEE ACHIEVES FULL EXTENSION AND WELL OVER 90 DEGREES OF FLEXION. IT IS WORTH NOTING THAT THE PATIENT ALSO HAS A VANGUARD TKA IN THE RIGHT KNEE WITH NO PROBLEMS. PLEASE NOTE THE SURGEON DOES NOT BELIEVE THE REVISION IS ANYTHING TO DO WITH THE PROSTHESES. NO X-RAYS OR OPERATIVE NOTES WILL BE SUPPLIED.

  Patient problems: Failure of Implant

  MAUDE report 13900510 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050222, K113550, K171054. One submission often covers many models, so check the product and lot details in each record.

• Z-1607-2024 · Mar 13, 2024 · Open, Classified
  Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyureth
• 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-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