Duracon 6642-5-311Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540318916), received between Feb 5, 2019 and Feb 5, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (1 report).

1 other recall cover devices cleared under the same FDA submission (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2019Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO EXCESSIVE INSERT WEAR. SURGEON REPORTED CONTRIBUTING FACTORS: IMPLANTED FOR 14 YEARS, AND PATIENT WEIGHT GAIN OF OVER 200 POUNDS. A LARGE DURACON 11MM INSERT WAS REVISED TO A LARGE DURACON 28MM INSERT. REP PROVIDED THE PRIMARY OPERATIVE REPORT, PRE-REVISION X-RAY, REVISION IMPLANT SHEET, AND DEVICE PICTURES AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 8304872 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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