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Triathlon 5513-F-601Recalls & reported problems

Howmedica Osteonics Corp. · Cruciate Retaining Femoral · 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
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327040463), received between Jul 13, 2017 and Jul 13, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (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

  • Packaging Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJul 13, 2017Packaging Problem; Packaging Problem

    CUSTOMER REPORTED THAT THE PRODUCT IS DEFECTIVE. DURING A PROCEDURE THEY NOTICED THAT THE PACKAGING WAS PERFORATED. THEY DID NOT USE IT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6710690 ↗

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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