Evolis Total Knee System 3010.004DRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630030844522), received between Sep 25, 2019 and Sep 25, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.

• InjurySep 25, 2019Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED AFTER 9 YEARS AND 10 MONTHS FROM THE PRIMARY DUE TO INSTABILITY WHICH WAS CAUSED BY A LOOSE TIBIAL TRAY AND FEMORAL COMPONENT. THE SURGEON REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT SUCCESSFULLY. THE PRIMARY IMPLANTS WERE NOT CEMENTED.

  Patient problems: Joint Disorder

  MAUDE report 9115067 ↗

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