Duracon 6478-6-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327045024), received between Feb 3, 2020 and Jul 31, 2025 — 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.

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

  INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: FEMORAL STEM LOOSENING. REQUIRED REVISION ON OF THE R SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22673408 ↗
• InjuryDec 12, 2022Fracture; Fracture

  AT THE OUTPATIENT CHECK-UP ON (B)(6) 2022, THE X-RAYS SHOWED RUPTURE OF THE FEMORAL STEM WITH A DISCONNECTION BETWEEN THE MRH COMPONENT OF THE FEMORAL PROSTHETIC SHIELD AND THE FEMORAL STEM. ON (B)(6) 2022, THE COMPLETE REVISION SURGERY OF THE MRH SIZE SMALL FEMORAL COMPONENT AND NEW 15X155MM FEMORAL STEM WERE PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 15965315 ↗
• InjuryFeb 3, 2020Fracture; Fracture

  AS REPORTED: "PATIENT REQUIRED REVISION DUE TO A FRACTURE OF THE 15X155MM STEM AT THE BASE OF THE THREADS, BETWEEN THE STEM AND MRH FEMORAL COMPONENT." SPOKE TO REP, WHO PROVIDED PRIMARY AND REVISION USAGE SHEETS FOR THE PATIENT'S RIGHT KNEE. NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9659566 ↗

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