Duracon 6478-6-720Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327045048), received between Aug 1, 2018 and Aug 5, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: PROSTHETIC JOINT INFECTION REQUIRED I&D. NO COMPONENTS WERE REMOVED. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22713668 ↗
• InjuryDec 21, 2018Fracture; Fracture

  IT WAS REPORTED THAT GMRS STEM IS BROKEN AFTER THE PATIENT FELL, AS SEEN ON X-RAY. THE PATIENT FELT PAIN AND LIMITED KNEE JOINT MOTION.

  Patient problems: Fall; Injury; Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 8190080 ↗
• InjuryAug 1, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION BEYOND THAT WHICH HE PROVIDED ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7739567 ↗

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