Duracon 6478-6-615Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327044881), received between Mar 30, 2021 and May 7, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryMay 7, 2022Fracture; Fracture

  SURGEON REPORTED THAT A REVISION SURGERY IS REQUIRED TO A PATIENT WITH AN IMPLANTED GMRS STEM, NOW IDENTIFIED BEING BROKEN.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14321669 ↗
• InjuryMar 30, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT SPECIFIC SOLUTIONS REQUEST WAS RECEIVED FOR THE PATIENT'S RIGHT DISTAL FEMUR WITH NOTES: "UNDERWENT CONSTRAINED TKA WITH STRYKER COMPONENTS AND AFTER INITIAL POSTOP PERIOD OF DOING WELL HAS HAD PERSISTENT OSTEOLYSIS, PAIN AND DECREASING FUNCTION. ALLERGY TESTING REVEALED NICKEL ALLERGY AND MULTIPLE BLOOD AND ASPIRATIONS OF THE JOINT HAVE BEEN NEGATIVE FOR INFECTION." A NICKEL FREE DISTAL FREE FEMUR IMPLANT IS BEING REQUESTED WITH A PLANNED DATE OF SURGERY (B)(6) 2021.

  Patient problems: Inflammation; Pain

  MAUDE report 11591256 ↗

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