Duracon 6478-6-620Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327044898), received between Dec 1, 2020 and May 5, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (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 16, 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.

• InjuryMay 5, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  PATIENT WAS REVISED DUE TO A FRACTURED DISTAL FEMUR AND THE FEMORAL COMPONENT STEM WAS DISASSOCIATED FROM THE BODY OF THE FEMORAL COMPONENT DUE TO IT BREAKING THROUGH THE THREADS OF THE STEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 16874354 ↗
• 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 11591340 ↗
• InjuryDec 1, 2020Fracture; Unstable; Fracture; Unstable

  THE CEMENTED SHAFT WAS SEPARATED FROM THE FEMUR. THE ITEM WAS EXPLANTED ON (B)(6) AND REPLACED BY A GMRS FEMUR (DIATAL FEMORAL REPLACEMENT). INITIAL IMPLANTATION TOOK PLACE IN 2017. SINCE ONE WEEK INSTABILITY WAS NOTICEABLE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 10926755 ↗

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