Vanguard® Knee System 183108Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304270794), received between Sep 19, 2019 and Oct 19, 2022 — classified as 3 injuries.

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

2 FDA recall records name this device's identifier, 1 still open.

18 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.

Recalls naming this device

1. Dec 29, 2022Class IIOpen, Classified

   Components Incorrectly labeled as either smaller or larger and incorrect side (right/left).

   Z-1042-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

2. Oct 22, 2018Class IITerminated

   Label on the outer carton or the patient labels does not match label on the inner sterile packaging

   Z-0495-2019 · Root cause: Labeling mix-ups · Recall details · FDA record ↗

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.

• InjuryOct 19, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL KNEE REPLACEMENT APPROXIMATELY ONE YEAR AGO DUE TO PAIN. THE PATIENT ALLEGES THAT THE OPERATING PHYSICIAN STATED THAT THE PATIENT'S IMPLANT HAD SHIFTED AND THE PATIENT REPORTED HAVING A SIMILAR PAIN FROM THEIR LEG TO THEIR ANKLE AND DOWN THEIR LEG AS THEY DID PRIOR TO THE SURGERY. THE PATIENT FURTHER ALLEGED THAT THEIR NEW SURGEON ADVISED THAT THE IMPLANT WAS TOO LARGE AND WOULD NEED TO BE REVISED. THE PATIENT IS SCHEDULED FOR A REVISION SURGERY; HOWEVER, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain

  MAUDE report 15635696 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT A WOUND DEBRIDEMENT AND RE-SUTURING UNDER LOCAL ANESTHESIA THREE DAYS POST IMPLANTATION DUE TO PAIN AND WOUND DRESSING OOZING BLOOD. PATIENT WAS GIVEN REGULAR MEDICATION CHANGES, EXTENDED ANTIBIOTICS AND WAS CLOSELY MONITORED. THE WOUND HEALED WELL AND THE POSTOPERATIVE RECOVER WAS POSSIBLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Pain; Wound Dehiscence

  MAUDE report 14073783 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION REPORTED.

  Patient problems: Fibrosis; Loss of Range of Motion; Pain

  MAUDE report 9087867 ↗

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-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-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-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-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
• Z-2945-2011 · Jul 6, 2011 · Terminated
  Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. Biomet, Inc. A knee joint replacement prosthesis non-coated femoral indicated for ceme
• Z-2204-2010 · Apr 20, 2010 · Terminated
  Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component.

…and 3 more.