Duracon 6478-6-690Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327044997), received between Sep 25, 2018 and Sep 25, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K223069, K973164); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2018Break; Fracture; Loss of Osseointegration; Break; Fracture; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING OF THE FEMUR AND TIBIA, AS WELL AS A BROKEN FEMORAL STEM AT THE STEM/OFFSET BOLT INTERFACE. REP REPORTED THE PATIENT'S ENTIRE KNEE WAS REVISED.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7908430 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223069, K973164. One submission often covers many models, so check the product and lot details in each record.

• Z-0362-2016 · Sep 21, 2015 · Terminated
  Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, m