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Triathlon 5531-P-512Recalls & reported problems

Howmedica Osteonics Corp. · Tibial Bearing Insert - CS · 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 07613327391237), received between Sep 17, 2023 and Sep 17, 2023 — classified as 1 injury.

3 other recalls cover devices cleared under the same FDA submission (K173849); 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 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Pain1

Recent adverse event reports

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

  • InjurySep 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "THE REVISION TODAY WAS SECONDARY TO PATELLA PAIN. THE PATELLA WAS RESURFACED AND THE POLY WAS EXCHANGED TO ACCESS THE BACK OF THE KNEE TO WASHOUT AND INJECT LOCAL ANESTHETIC. THERE WAS NO MENTION OF THE USE OF MAKO IN THE PRIMARY PROCEDURE BEING RELEVANT TO TODAY¿S REVISION. (REGARDING WASTED IMPLANT LISTED ON INDEX USAGE) I AM ALSO NOT SURE WHY A 10MM INSERT WAS REPLACED WITH A 12MM INSERT IN THE INDEX SURGERY. NO FURTHER INFORMATION IS AVAILABLE FROM THE SURGEON OR HOSPITAL."

    Patient problems: Pain

    MAUDE report 17762385 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173849. One submission often covers many models, so check the product and lot details in each record.

  • Z-1260-2024 · Feb 6, 2024 · Open, Classified
    X3 TRIATHLON CS INSERT NO 6 10 MM
  • Z-1259-2024 · Feb 6, 2024 · Open, Classified
    X3 TRIATHLON CS INSERT NO 3 10 MM
  • Z-1653-2023 · Apr 13, 2023 · Open, Classified
    TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-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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