Triathlon 5534-A-709Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327043372), received between Nov 10, 2022 and Nov 10, 2022 — classified as 1 injury.

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

• InjuryNov 10, 2022Adverse 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. DURING THE FOLLOW-UP QUESTIONNAIRE BETWEEN THE PATIENT AND THE STUDY COORDINATOR TO COLLECT INFORMATION ABOUT THE KNEE FOR THE STUDY, THE PATIENT REPORTED HE WAS NOT SATISFIED WITH THE RESULTS OF THE KNEE SURGERY AND WAS STILL EXPERIENCING PAIN. HE DESCRIBED IT AS " A LITTLE PAIN" AND A FURTHER COMMENT WHEN ASKED IF HE WAS SATISFIED WITH THE KNEE SURGERY HE SAID, "NOT REALLY. I HAVE HAD PAIN SINCE THE BEGINNING." NO CLINIC EVALUATION BY THE SURGEON WAS DONE AT THIS TIME.

  Patient problems: Pain

  MAUDE report 15769332 ↗