Duracon 6478-6-600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327044850), received between Oct 9, 2018 and Mar 9, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "STEM LOOSENING AT THE BOSS JUNCTION. (REVISED COMPONENTS) SMALL MRH FEMUR WITH 10MM AUGMENTS MEDIAL LATERAL, 10X80 STEM AND MODULAR COMPONENTS." SPOKE TO REP. THE STEM WAS BEGINNING TO COME UNTHREADED FROM THE FEMORAL COMPONENTS. THERE ARE NO ALLEGATIONS AGAINST THE REVISED AUGMENTS OR MODULAR COMPONENTS. AN MRH FEMORAL COMPONENT WITH STEM, AUGMENTS AND BLOCKS, TIBIAL SLEEVE, INSERT, AND TIBIAL ROTATING COMPONENT WERE IMPLANTED, AND THE PATIENT'S NATIVE PATELLA WAS RESURFACED. REP PROVIDED USAGE SHEETS FOR PRIMARY AND REVISION, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 11447416 ↗
• InjuryOct 9, 2018Mechanical Problem; Loss of Osseointegration; Mechanical Problem; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO MECHANICAL FAILURE AND LOOSENING (SURGEON WOULD NOT REPORT MORE THAN THAT TO THE REP). AN MRH CONSTRUCT OF 11 DEVICES EXCEPT THE TIBIAL BASEPLATE WAS REVISED TO AN MRH CONSTRUCT WITH AN ADDITIONAL CONE AUGMENT.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7948661 ↗

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