Evolis Total Knee System 3031.0205Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030845284), received between Aug 20, 2018 and Jan 17, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 reports).

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 18, 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.

• InjuryJan 17, 2020Loose or Intermittent Connection

  REVISION SURGERY PERFORMED ON (B)(6) 2019 DUE TO A TIBIAL LOOSENING . PRIMARY SURGERY TOOK PLACE IN 2004, EXACT DATE UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9601766 ↗
• InjuryAug 20, 2018Loose or Intermittent Connection; Improper or Incorrect Procedure or Method

  REVISION DUE TO TIBIAL TRAY LOOSENING AND SUBSIDENCE 5 YEARS AFTER PRIMARY. THE PATIENT HAVING A HIGH BMI; NO EXTENSION STEM WAS IMPLANTED IN THE PRIMARY CASE. THE FEMORAL COMPONENT WAS LEFT IN SITU. THE SALES REPRESENTATIVE WAS INFORMED ABOUT THE EVENT BY THE SURGEON ON 28 JUNE 2018. DUE TO HUMAN ERROR, THE SALES REPRESENTATIVE INFORMED THE HEADQUARTER ON 10 AUGUST 2018.

  Patient problems: No Code Available

  MAUDE report 7797182 ↗

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