Triathlon 5534-A-609Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327043334), received between May 15, 2023 and Jan 30, 2025 — classified as 2 injuries.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE RIGHT KNEE. AS NOTED ON THE 7YR AND 8YR VISIT OF THE FOLLOW-UP QUESTIONNAIRE (BOTH COLLECTED OVER THE PHONE), THE SUBJECT NOTED NO TO THEIR SATISFACTION WITH THE KNEE REPLACEMENT. THE COORDINATOR COMMENT STATES THAT PATIENT HAS PAIN IN BOTH KNEES. THE SUBJECT NOTED DURING BOTH VISITS "THE PAIN IS CONSTANT IN BOTH KNEES" HOWEVER ALSO NOTED DURING THE 7YR VISIT "THE RIGHT KNEE IS WORSE." THERE ARE NO RADIOGRAPHS OR PHYSICAL EXAM NOTES TO PROVIDE.

  Patient problems: Pain

  MAUDE report 21272557 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT IS PART OF THE TRIATHLON ALL-POLYETHYLENE TIBIA RETROSPECTIVELY ENROLLED AND PROSPECTIVELY FOLLOWED CLINICAL STUDY. THE PATIENT COMPLAINED ABOUT EXCESSIVE KNEE PAIN AT A VISIT AN ADVERSE EVENT WAS CREATED. THE EVENT WAS DEEMED RESOLVED AS OF (B)(6) 2021WITH THE HELP OF FORMAL THERAPY. SINCE THIS IS A RETROSPECTIVE STUDY, SITE CAN NOT PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: Pain

  MAUDE report 16929583 ↗