Vanguard® Knee System 183024Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304270497), received between Sep 16, 2019 and Feb 17, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT KNEE REVISION APPROXIMATELY 3.5 YEARS POST IMPLANTATION DUE TO INSTABILITY. THE FEMORAL COMPONENT AND ARTICULAR SURFACE WERE REMOVED AND REPLACED.

  Patient problems: No Information

  MAUDE report 9717618 ↗
• InjurySep 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA TO ADDRESS KNEE STIFFNESS AND LIMITED RANGE OF MOTION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Loss of Range of Motion; No Code Available

  MAUDE report 9069616 ↗

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-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.