Vanguard M Partial Knee System US154700Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Vanguard M Partial Knee System (20)
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 00880304180611), received between May 9, 2024 and May 9, 2024 — classified as 1 injury.
2 other recalls cover devices cleared under the same FDA submission (K042093); 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
- Low Blood Pressure/ Hypotension1
- Pneumonia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED A PATIENT HAD AN INITIAL LEFT UNICOMPARTMENTAL KNEE ARTHROPLASTY AND DEVELOPED PNEUMONIA AND HYPOTENSION WITHIN A WEEK OF THE PROCEDURE. NO FURTHER DISCUSSION OR INFORMATION REGARDING INTERVENTION OR OUTCOME WAS PROVIDED.
Patient problems: Low Blood Pressure/ Hypotension; Pneumonia
MAUDE report 19278187 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K042093. One submission often covers many models, so check the product and lot details in each record.
- Z-2155-2020 · Apr 17, 2020 · TerminatedKnee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vanguard M Partial Knee System MonoBlock Tibial Tra
- Z-1798-2015 · Apr 22, 2015 · TerminatedVanguard M Unicondylar Tibial Trial For use during knee joint replacement.
Other PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- R3 71363077Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER461 reports
- NA 71364009Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER174 reports
- JOURNEY 74012415Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012416Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012414Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER129 reports
- GENESIS II 71440194Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER114 reports
- GENESIS II 71440842Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER113 reports
- JOURNEY 74018901Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER106 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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