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Triathlon 5534-A-413Recalls & reported problems

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

All models of Triathlon (608)

Data updated Oct 16, 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 07613327043273), received between Mar 11, 2022 and Mar 11, 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 16, 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.

  • InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT UNDERWENT RIGHT INDEX TKA OUTSIDE CORS SCOPE. PATIENT PRESENTS WITH PAIN AND IS STUDIED FOR INFECTION. SHE IS REVISED FOR PJI ON (B)(6) 2021. ALL COMPONENTS WERE EXCHANGED (USED AN ALL POLY TIBIA). PATIENT PERSISTS WITH INFECTION AND SHE IS REVISED AGAIN FOR PJI ON (B)(6) 2021. ALL COMPONENTS EXCHANGED.

    Patient problems: Unspecified Infection

    MAUDE report 13728877 ↗

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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