Triathlon 5535-A-509Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327043617), received between Mar 13, 2023 and Apr 21, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

Recent adverse event reports

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

• InjuryApr 21, 2026Mechanical Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: THE SUBJECT EXPERIENCED POST-OPERATIVE ARTHROFIBROSIS, OCCURRING IN THE POST-OPERATIVE PERIOD. DUE TO LIMITED RANGE OF MOTION BEFOREHAND, A MANIPULATION UNDER ANESTHESIA WAS PERFORMED. THE EVENT WAS NOT DEVICE-RELATED, AND DID NOT RESULT IN DEATH.

  Patient problems: Loss of Range of Motion

  MAUDE report 24938359 ↗
• InjuryMar 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT WHEN IMPLANTING THE ALL-POLY TIBIA, PATIENT'S TIBIA FRACTURED. THE IMPLANT WAS REMOVED AND CONSTRUCT WAS CONVERTED TO REVISION IMPLANTS. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 45 MINUTES.

  Patient problems: Bone Fracture(s)

  MAUDE report 16527555 ↗