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Biomet® Knee System 148297Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

All models of Biomet Knee System (72)

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 00880304528932), received between Mar 25, 2021 and Mar 25, 2021 — classified as 1 injury.

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

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. APPROXIMATELY 5 YEARS POST IMPLANTATION, THE PATIENT WAS REVISED FOR AN UNKNOWN REASON. SUBSEQUENTLY, THE PATIENT UNDERWENT ANOTHER REVISION 3 YEARS LATER DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Patient problems: Insufficient Information

    MAUDE report 11568812 ↗

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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