Evolis Total Knee System 3040.0209Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030845352), received between Jan 19, 2024 and Jan 19, 2024 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K081023); 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

Recent adverse event reports

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

• InjuryJan 19, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 7 YEARS AND 11 MONTHS AFTER THE PRIMARY SURGERY DUE TO IRRITABLE KNEE. SURGEON DISCOVERED SYNOVITIS IN JOINT AND REVISED THE LINER.

  Patient problems: Inflammation

  MAUDE report 18541560 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081023. One submission often covers many models, so check the product and lot details in each record.

• Z-2095-2010 · Sep 11, 2009 · Terminated
  Evolis-Femoral Sizer Posterior Reference The femoral sizer posterior reference is a manual orthopedic surgical instrument that is used to determine the trial size and set the exte