Duracon 6478-6-715Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327045031), received between Apr 24, 2019 and Jul 31, 2025 — classified as 3 injuries.

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

• InjuryJul 31, 2025Loss of Osseointegration; Loss of Osseointegration

  THE FOLLOWING WAS REPORTED: "ASEPTIC LOOSENING. ALL COMPONENTS REMOVED. LEFT KNEE."

  Patient problems: Inadequate Osseointegration

  MAUDE report 22680395 ↗
• InjuryNov 27, 2019Fracture; Fracture

  PATIENT WITH MRH IN SITU. PATIENT HAS STABILITY PROBLEMS. DURING SURGERY THEY DISCOVER A LOOSE FEMUR COMPONENT. WHEN COMPONENT HAS BEEN REMOVED THEY DISCOVER THAT THE STEM UNDER THE FEMUR COMPONENT HAS BEEN BROKEN. IT TOOK A LOT OF EFFORT TO TAKE OUT THE BROKEN STEM. DURING THIS EXTRACTION THE FEMUR BROKE. PATIENT NOW NEEDS ANOTHER SURGERY FOR A GMRS.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Injury

  MAUDE report 9385714 ↗
• InjuryApr 24, 2019Break; Break

  ASEPTIC MOBILIZATION OF LEFT KNEE PROSTHESIS WITH BROKEN STEM IMPLANTED ON 2011.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8544202 ↗

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