Duracon 6478-6-640Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327044935), received between Apr 15, 2019 and Aug 5, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 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, 2025Loss of Osseointegration; Loss of Osseointegration

  INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: ASEPTIC LOOSENING. ALL COMPONENTS REMOVED. LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22720191 ↗
• InjuryJul 9, 2025Loss of Osseointegration; Loss of Osseointegration

  REVISION OF MRH FEMUR WITH PRESS-FIT STEM, FOUND LOOSE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22459268 ↗
• InjuryApr 15, 2019Osseointegration Problem; Osseointegration Problem

  LOOSENING OF THE MRH PROSTHESIS IN THE FEMORAL AREA. STEM LOOSENED FROM FEMUR.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8515273 ↗

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