Evolis Total Knee System 3052.0039Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030846564), received between Nov 13, 2018 and Nov 13, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

• InjuryNov 13, 2018Device Dislodged or Dislocated

  THE PATIENT COMPLAINED OF PAIN DUE TO LUXATION OF THE PATELLA NOTICED AFTER RADIOLOGICAL EXAMINATION DONE 17 DAYS AFTER PRIMARY. INSERT, FEMORAL AND TIBIAL COMPONENTS IMPLANTED IN (B)(6) 2016 WERE REVISED. THE PATELLA WAS LEFT IN PLACE. NOTE: EVENT HAPPENED IN (B)(6) 2017 AND NOTIFIED IN OCTOBER 2018.

  Patient problems: Joint Disorder

  MAUDE report 8064119 ↗

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