Duracon 6478-6-405Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327044676), received between May 24, 2018 and May 24, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 18, 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.

• InjuryMay 24, 2018Break; Fracture; Loss of Osseointegration; Break; Fracture; Loss of Osseointegration

  OR MANAGER AT THE CLINIC, REPORTED THE FOLLOWING EVENT : "REVISION SURGERY OF LEFT KNEE PROSTHESIS FOR FEMORAL LOOSENING. OBSERVATION OF RUPTURE OF THE FEMORAL STEM. UPDATE 23 MAY 2018: FRACTURED STEM WAS RETURNED WITH THE FEMORAL COMPONENT - IT IS NOTED THAT THE STEM HAS FRACTURED ON THE THREADED SECTION. PORTION OF THREADED SECTION REMAINS INSIDE FEMORAL COMPONENT.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7540450 ↗