Vanguard® Knee System 183050Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304270626), received between May 6, 2022 and Jan 29, 2026 — classified as 2 injuries, 1 malfunction.

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

20 other recalls cover devices cleared under the same FDA submission (K023546, K033489, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Inaccurate Information

  IT WAS REPORTED THAT A CEMENTLESS FEMORAL COMPONENT WAS IMPLANTED DURING A TOTAL KNEE ARTHROPLASTY, AND A DISCREPANCY WAS LATER NOTED WHEREIN THE PATIENT LABEL IDENTIFIED THE DEVICE AS CEMENTED. PRIOR TO IMPLANTATION, THE SURGICAL TEAM CONFIRMED WITH THE SURGEON THAT CEMENTLESS FIXATION WOULD BE USED. THE CIRCULATING NURSE OPENED THE PACKAGE, AND THE OUTER PACKAGING (BOX LID) INDICATED A CEMENTLESS/POROUS COMPONENT. SUBSEQUENTLY, IT WAS POINTED OUT THAT THE PATIENT LABEL INDICATED A CEMENTED VARIANT, WHILE THE IMPLANTED COMPONENT AND OUTER PACKAGING CORRESPONDED TO CEMENTLESS. THE PATIENT HAD NO KNOWN IMPACT OR CONSEQUENCE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209251 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TKA ON AN UNKNOWN DATE. SUBSEQUENTLY, THEY WERE REVISED DUE TO PAIN AND STIFFNESS. ALL FORMER IMPLANTS WERE REPLACED. TO ADDRESS THE OVERALL TIGHTNESS IN BOTH FLEXION AND EXTENSION, THE SURGEON DOWNSIZED THE FEMORAL COMPONENT, RESECTED MORE BONE OFF THE FEMUR AND TIBIA AND DEBRIDEMENT SIGNIFICANT AMOUNTS OF SCAR TISSUE. ATTEMPTS HAVE BEEN MADE, AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 23295452 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT A KNEE SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED LAST YEAR DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 14307953 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023546, K033489, 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-0495-2019 · Oct 22, 2018 · Terminated
  Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126
• Z-0496-2019 · Oct 22, 2018 · Terminated
  Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108
• 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.