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Triathlon 5534-A-509Recalls & reported problems

Howmedica Osteonics Corp. · Tibial Component · Class 2 · Implant

All models of Triathlon (608)

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 07613327043297), received between Dec 6, 2022 and Dec 6, 2022 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE FOLLOWING WAS REPORTED: THIS PATIENT WAS PART OF THE TRIATHLON ALL-POLYETHYLENE TIBIA (APT) RETROSPECTIVELY ENROLLED AND PROSPECTIVELY FOLLOWED CLINICAL STUDY. THE SITE NEEDED CONSENT TO LOOK AT THE MEDICAL RECORD AND UPON OBTAINING CONSENT, THE SITE FOUND OUT THAT A 2-STAGE REVISION WAS PERFORMED DUE TO JOINT INFECTION. A STRYKER TRIATHLON PRESS-FIT KNEE WAS REMOVED; THE APT DEVICE WAS USED AS A SPACER.

    Patient problems: Unspecified Infection

    MAUDE report 15925652 ↗

Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices →

Sources and updates

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