VANGUARD KNEE SYSTEM 183099Recalls & reported problems
Biomet Orthopedics, LLC · Class 2 · Implant
Quick summary
This Biomet Vanguard knee system is an artificial knee implant used in knee replacement surgery. The 29 reports describe packaging problems — torn or ripped inner bags, and in one case a product delivered without proper sterilization — found when the package was opened in the operating room. No deaths or injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00880304447646), received between Dec 9, 2021 and Jun 13, 2023 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (19 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Tear, Rip or Hole in Device Packaging19
- Packaging Problem15
- Delivered as Unsterile Product1
Patient problems
- No Clinical Signs, Symptoms or Conditions29
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2023Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17118207 ↗MalfunctionJun 6, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING AN INITIAL KNEE SURGERY, THE OUTER PACKAGING OF A PACKAGE OF THE FEMORAL PEGS WAS OPENED AND IT WAS DISCOVERED THAT THE INNER BAGS WERE TORN. ANOTHER PACKAGE WAS ALSO OPENED, HOWEVER, THE INNER BAGS WERE ALSO TORN. THERE WAS NO SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17070896 ↗MalfunctionJun 6, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT DURING AN INITIAL KNEE SURGERY, THE OUTER PACKAGING OF A PACKAGE OF THE FEMORAL PEGS WAS OPENED AND IT WAS DISCOVERED THAT THE INNER BAGS WERE TORN. ANOTHER PACKAGE WAS ALSO OPENED, HOWEVER, THE INNER BAGS WERE ALSO TORN. THERE WAS NO SURGICAL DELAY. THE SURGICAL TECHNIQUE WAS UTILIZED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17070895 ↗MalfunctionMay 31, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029804 ↗MalfunctionMay 31, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17029790 ↗MalfunctionMay 23, 2023Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16987444 ↗MalfunctionMay 23, 2023Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16987438 ↗MalfunctionMay 9, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16897311 ↗MalfunctionMay 4, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16873711 ↗MalfunctionMay 4, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16873710 ↗MalfunctionMay 2, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED. WHEN THE VANGUARD DISTAL FEMORAL PEG PACKAGE WAS OPENED, THE INNER BAGS WERE TORN WITHIN THE STERILE POUCH. ANOTHER PACKAGE WAS OPENED AND THE INNER BAGS WERE TORN AS WELL. SUBSEQUENTLY, THE SURGEON DECIDED TO USE THE SECOND PEGS TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16854707 ↗MalfunctionMay 2, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT TOTAL KNEE ARTHROPLASTY WAS PERFORMED. WHEN THE VANGUARD DISTAL FEMORAL PEG PACKAGE WAS OPENED, THE INNER BAGS WERE TORN WITHIN THE STERILE POUCH. ANOTHER PACKAGE WAS OPENED AND THE INNER BAGS WERE TORN AS WELL. SUBSEQUENTLY, THE SURGEON DECIDED TO USE THE SECOND PEGS TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16854700 ↗MalfunctionApr 27, 2023Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16826721 ↗MalfunctionApr 26, 2023Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16816127 ↗MalfunctionApr 20, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16782395 ↗MalfunctionApr 19, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT AN IMPLANT HAD INNER BAG COVERING TORN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16769520 ↗MalfunctionApr 17, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16753475 ↗MalfunctionApr 11, 2023Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16713305 ↗MalfunctionApr 11, 2023Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16713301 ↗MalfunctionApr 11, 2023Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16713264 ↗MalfunctionApr 11, 2023Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16713217 ↗MalfunctionMar 30, 2023Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16643374 ↗MalfunctionMar 30, 2023Packaging Problem; Packaging Problem
IT WAS REPORTED, THAT DURING A KNEE PROCEDURE, AS THE PACKAGING TO THE FEMORAL PEGS WAS OPENED, THE INNER STERILE BAG TORE, AND THE IMPLANTS DROPPED. AN ISSUE WAS NOTED WITH THE STERILE PACKAGING ON TWO ADDITIONAL IMPLANTS. THE PROCEDURE WAS COMPLETED USING A FOURTH SET OF PEGS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16643362 ↗MalfunctionMar 30, 2023Packaging Problem; Packaging Problem
IT WAS REPORTED THAT DURING A KNEE PROCEDURE, AS THE PACKAGING TO THE FEMORAL PEGS WAS OPENED, THE INNER STERILE BAG TORE, AND THE IMPLANTS DROPPED. AN ISSUE WAS NOTED WITH THE STERILE PACKAGING ON TWO ADDITIONAL IMPLANTS. THE PROCEDURE WAS COMPLETED USING A FOURTH SET OF PEGS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16643328 ↗MalfunctionMar 28, 2023Packaging Problem; Packaging Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16631736 ↗
Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices
- ATTUNE 1512-14-050Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER106 reports
- ATTUNE 1504-40-205Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall53 reports
- ATTUNE 1504-40-105Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall46 reports
- ATTUNE 1547-06-001Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall37 reports
- ATTUNE 1513-12-060Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER72 reports
- Triathlon 5521-B-300Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5531-G-709-EHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- ATTUNE 1512-16-080Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall16 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.