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Duracon 6478-6-400Recalls & reported problems

Howmedica Osteonics Corp. · Cobalt Chrome Stem · Class 2 · Implant

All models of Duracon (58)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327044669), received between May 26, 2022 and May 26, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).

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

Device problems

  • Loss of Osseointegration1

Patient problems

  • Inadequate Osseointegration1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 26, 2022Loss of Osseointegration; Loss of Osseointegration

    PATIENT HAD A LEFT KNEE SURGERY WHERE STRYKER COMPONENTS WERE IMPLANTED ON (B)(6)2019. PATIENT WAS REVISED ON (B)(6) 2020 FOR LOOSENING.

    Patient problems: Inadequate Osseointegration; Pain

    MAUDE report 14506554 ↗

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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