Duracon 6478-6-685Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327044980), received between Sep 12, 2019 and Nov 17, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO THE STEM BREAKING AT THE JUNCTION WITH THE FEMORAL COMPONENT OF A HINGED KNEE CONSTRUCT. REVISING SURGEON REPORTED HE FEELS THE FEMORAL SIDE SHOULD HAVE BEEN A DISTAL FEMORAL REPLACEMENT. THE PATIENT'S MRS/ MRH KNEE COMPONENTS (EXCEPT FOR THE PROXIMAL TIBIAL COMPONENT AND STEM) WERE REVISED. REP PROVIDED ALL INFORMATION THAT WAS AVAILABLE FROM THE HOSPITAL AND SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 18158258 ↗
• InjuryApr 8, 2021Fracture; Fracture

  PATIENT HAD MRH KNEE IMPLANTED. THE STEM / FEMUR INTERFACE APPEARED DAMAGED. FEMORAL COMPONENT REVISED TO GMRS DISTAL FEMUR. SPOKE TO REP. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED AUGMENTS AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 11634192 ↗
• InjurySep 12, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO A BROKEN MRH STEM. THE MRH SMALL FEMUR, 11X155 CEMENTED STEM, ROTATING COMPONENT, BUSHINGS, AXLE, AND TIBIAL SLEEVE WERE REVISED.

  Patient problems: Injury

  MAUDE report 9005873 ↗

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