Biomet® Knee System 148309Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304545564), received between Jun 9, 2020 and Jun 15, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (1 report).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blister; Chills; Depression; Dizziness; Eczema; Hypersensitivity/Allergic reaction; Pain; Rash

  MAUDE report 17133896 ↗
• MalfunctionJun 9, 2020Packaging Problem; Packaging Problem

  THE DEVICE WAS RETURNED WITH PACKAGING DAMAGE AND THE STERILITY BARRIER WAS POTENTIALLY COMPROMISED.

  Patient problems: No Patient Involvement

  MAUDE report 10133756 ↗