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Triathlon 5531-G-419-ERecalls & reported problems

Howmedica Osteonics Corp. · Tibial Bearing Insert - CS · 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 07613327336498), received between Apr 11, 2022 and Apr 11, 2022 — classified as 1 injury.

7 other recalls cover devices cleared under the same FDA submission (K172634); 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

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.

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

    DR. AT HOSPITAL EXPLANTED A RIGHT TRIATHLON KNEE ORIGINALLY DONE BY A DIFFERENT DR. AT ANOTHER FACILITY. IT WAS BELIEVED THAT THE KNEE IN WAS ALREADY REVISED TIBIA. THE TIBIA WAS A UNIVERSAL BASEPLATE WITH TWO 10MMM AUGMENTS. NO OTHER INFO WAS AVAILABLE. THIS WAS DUE TO INFECTION SO THIS WAS A FIRST STAGE EXPLANT TO CEMENT SPACER. ORIGINAL WAS A CR FEMUR.

    Patient problems: Unspecified Infection

    MAUDE report 14073947 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172634. One submission often covers many models, so check the product and lot details in each record.

  • Z-1264-2024 · Feb 6, 2024 · Open, Classified
    NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
  • Z-1262-2024 · Feb 6, 2024 · Open, Classified
    X3 TRIATHLON CS INSERT NO 7 9 MM
  • Z-1265-2024 · Feb 6, 2024 · Open, Classified
    NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
  • Z-1263-2024 · Feb 6, 2024 · Open, Classified
    NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
  • Z-1261-2024 · Feb 6, 2024 · Open, Classified
    X3 TRIATHLON CS INSERT NO 6 11 MM
  • Z-1266-2024 · Feb 6, 2024 · Open, Classified
    NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
  • Z-1654-2023 · Apr 13, 2023 · Open, Classified
    TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E

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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