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Triathlon 5530-P-611Recalls & reported problems

Howmedica Osteonics Corp. · Tibial Bearing Insert · 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 07613327041880), received between May 19, 2021 and May 19, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of Osseointegration” (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

  • Loss of Osseointegration1
  • Microbial Contamination of Device1

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.

  • InjuryMay 19, 2021Microbial Contamination of Device; Loss of Osseointegration; Microbial Contamination of Device; Loss of Osseointegration

    IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION AND SEPTIC LOOSENING. A FEMORAL COMPONENT, INSERT, TIBIAL BASEPLATE WITH 4 CANCELLOUS SCREWS AND A PATELLAR COMPONENT WERE REMOVED AND A SPACER WAS PLACED. SPOKE TO REP, WHO PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Unspecified Infection

    MAUDE report 11848651 ↗

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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