Triathlon 5510-F-802Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327040364), received between Apr 5, 2023 and Oct 10, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

• InjuryOct 10, 2023Fracture; Fracture

  FEMORAL COMPONENT IMPLANTED IN 2017 HAD TO BE REMOVED BECAUSE THE FEMORAL COMPONENT WAS FRACTURED AT THE TRANSITION BETWEEN THE ANTERIOR CHAMBER AND THE DISTAL PART. IMPLANTATION IN 2017 WAS UNREMARKABLE AND PERFORMED ACCORDING TO STANDARD PROCEDURE. EXPLANTATION AFTER PRESUMPTION OF LOOSENING OF THE COMPONENT, DISCOVERY OF THE BROKEN IMPLANT.

  Patient problems: Pain

  MAUDE report 17907271 ↗
• InjuryApr 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO THE MEDIAL FEMORAL CONDYLE OF THE FEMORAL COMPONENT BREAKING OFF. INTRA-OPERATIVELY, INSERT WEAR AND SHARP EDGES WERE NOTED. THE FEMORAL COMPONENT AND INSERT WERE REVISED. REP CONFIRMED THAT OTHER THAN PICTURES AND POSSIBLY IMPLANT INFORMATION, NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 16682518 ↗