Vanguard® Knee System 184702Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Vanguard Knee System (147)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868343964), received between Nov 12, 2025 and Nov 12, 2025 — classified as 1 injury.
17 other recalls cover devices cleared under the same FDA submission (K040770, 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Ambulation or Postural Difficulties1
- Ankylosis1
- Arthrofibrosis1
- Cyst(s)1
- Loss of Range of Motion1
- Nerve Damage1
- Neuropathy1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 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 RIGHT TOTAL KNEE ARTHROPLASTY. FOLLOWING THE PROCEDURE, THE PATIENT CONTINUED HAVING PAIN AND NEUROPATHY IN THE LEG WITH LIMITED RANGE OF MOTION. DIAGNOSTICS REVEALED DAMAGE TO THE PERONEAL NERVE RESULTING IN FOOT DROP AND DIFFICULTY AMBULATING. PHYSICAL EXAM REVEALED A PALPABLE BAKER¿S CYST, AND X-RAYS SHOWED EXCESSIVE TIBIAL SLOPE. SUBSEQUENTLY, APPROXIMATELY FOUR (4) MONTHS POST-IMPLANTATION, A MANIPULATION UNDER ANESTHESIA WAS PERFORMED DUE TO ANKYLOSIS AND ARTHROFIBROSIS. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Ambulation or Postural Difficulties; Ankylosis; Arthrofibrosis; Cyst(s); Loss of Range of Motion; Nerve Damage; Neuropathy; Pain; Swelling/ Edema
MAUDE report 23537496 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K040770, K171054. One submission often covers many models, so check the product and lot details in each record.
- Z-2154-2020 · Apr 17, 2020 · TerminatedKnee Products: 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM; 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM Product Usage: Knee prosth
- Z-0938-2019 · Dec 21, 2018 · TerminatedVanguard Knee System Series-A Standard Patella sizes 34mm Item Number: 184766
- Z-0937-2019 · Dec 21, 2018 · TerminatedVanguard Knee System Series-A Standard Patella sizes 31mm Item Number: 184764
- Z-2289-2018 · May 24, 2018 · TerminatedVanguard 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 · TerminatedBiomet 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 · TerminatedVanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
- Z-1861-2017 · Feb 17, 2017 · Terminatedvarious polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Pa
- Z-0695-2012 · Oct 4, 2011 · TerminatedBiomet Series A Thin Patella size 25mm, three pegs, Part 184780, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems. Knee join
- Z-0698-2012 · Oct 4, 2011 · TerminatedBiomet Series A Thin Patella size 25mm, one peg - 184720 Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofe
- Z-0701-2012 · Oct 4, 2011 · TerminatedBiomet Series A Standard Patella size 28mm, three pegs - 184762, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint p
- Z-0704-2012 · Oct 4, 2011 · TerminatedBiomet Series A Asymmetrical Patella size 28mm, three pegs - 184791, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee. J
- Z-0699-2012 · Oct 4, 2011 · TerminatedBiomet Series A Thin Patella size 25mm, one peg - 184720, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellof
- Z-0696-2012 · Oct 4, 2011 · TerminatedBiomet Series A Standard Patella size 25mm, one peg, Part 184700, Sterile, Biomet Orthopedics, Warsaw, IN 46582 Knee joint patellofemorotibial, cemented, polymer/metal/polymer, se
- Z-0703-2012 · Oct 4, 2011 · TerminatedBiomet Series A Asymmetrical Patella size 25mm, three pegs - 184790, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee. J
- Z-0702-2012 · Oct 4, 2011 · TerminatedBiomet Series A Thin Patella size 28mm, three pegs - 184782, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patel
…and 2 more.
Other Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive devices
- iTotal® PS TPS111111102Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive327 reports
- ATTUNE 1506-00-006Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive287 reports
- ATTUNE 1506-00-008Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive233 reports
- iTotal® Cruciate Retaining (CR) Knee Replacement System TCR121111102Conformis, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive150 reports
- ATTUNE 1506-70-007Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall2 deaths74 reports
- ATTUNE 1516-40-506Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive121 reports
- ATTUNE 1506-70-006Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 recall70 reports
- ATTUNE 1516-40-605Depuy (Ireland) · Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive120 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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