VANGUARD COMPLETE KNEE SYSTEM 195779Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
All models of Vanguard Complete Knee System (27)
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 00880304552937), received between Jan 13, 2021 and Jan 13, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).
22 other recalls cover devices cleared under the same FDA submission (K132873); 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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Loss of or Failure to Bond1
Patient problems
- Pain1
- Swelling1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 13, 2021Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Pain; Swelling
MAUDE report 11163489 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K132873. One submission often covers many models, so check the product and lot details in each record.
- Z-2521-2019 · Aug 15, 2019 · TerminatedXP-XP Tibial Tray - Interlok 73 mm Item # 195756
- Z-2506-2019 · Aug 15, 2019 · TerminatedXP-CR Tibial Tray - Interlok 67mm Item # 195271
- Z-2522-2019 · Aug 15, 2019 · TerminatedXP-XP Tibial Tray - Interlok 71 mm Item # 195755
- Z-2518-2019 · Aug 15, 2019 · TerminatedXP-XP Tibial Tray - Interlok 83 mm Item # 195759
- Z-2504-2019 · Aug 15, 2019 · TerminatedXP-CR Tibial Tray - Interlok 63mm Item # 195269
- Z-2525-2019 · Aug 15, 2019 · TerminatedXP-XP Tibial Tray - Interlok 65 mm Item # 195752
- Z-2510-2019 · Aug 15, 2019 · TerminatedXP-CR Tibial Tray - Interlok 75mm Item # 195275
- Z-2519-2019 · Aug 15, 2019 · TerminatedXP-XP Tibial Tray - Interlok 79 mm Item # 195758
- Z-2505-2019 · Aug 15, 2019 · TerminatedXP-CR Tibial Tray - Interlok 65mm Item # 195270
- Z-2512-2019 · Aug 15, 2019 · TerminatedXP-CR Tibial Tray - Interlok 83 mm Item # 195277
- Z-2517-2019 · Aug 15, 2019 · TerminatedXP-XP Tibial Tray - Interlok 87 mm Item # 195760
- Z-2524-2019 · Aug 15, 2019 · TerminatedXP-XP Tibial Tray - Interlok 67 mm Item # 195753
- Z-2523-2019 · Aug 15, 2019 · TerminatedXP-XP Tibial Tray - Interlok 69 mm Item # 195754
- Z-2514-2019 · Aug 15, 2019 · TerminatedXP-CR Tibial Tray - Interlok 91 mm Item # 195279
- Z-2511-2019 · Aug 15, 2019 · TerminatedXP-CR Tibial Tray - Interlok 79 mm Item # 195276
…and 7 more.
Other Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer devices
- Regenerex 141356Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall5 reports
- BIOMET KNEE SYSTEM 141215Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall3 reports
- Regenerex 141358Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall1 report
- Vanguard Knee System 189720Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall0 reports
- Vanguard Knee System 189704Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall0 reports
- Vanguard Knee System 189320Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall0 reports
- Vanguard Knee System EP-183608Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer1 recall0 reports
- Biomet® 360 Knee System 185204Biomet Orthopedics, LLC · Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer5 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.
How reports and recalls are matched · Editorial policy · Report an error on this page