Triathlon 5534-A-713Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327043396), received between Jan 13, 2025 and Jan 16, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (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.

• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: AS NOTED ON THE 7YR VISIT OF THE FOLLOW-UP QUESTIONNAIRE (COLLECTED OVER THE PHONE), THE SUBJECT NOTED NO TO THEIR SATISFACTION WITH THE RIGHT KNEE REPLACEMENT. THE SUBJECT STATED "ABOUT 80% SATISFIED, NOT WHAT EXPECTED, NEVER REGAINED FEELING IN FOOT AND KNEES, ALWAYS WARM." THE SUBJECT ALSO STATED THAT HE DOES HAVE KNEE PAIN, ONLY WHEN HE STANDS UP AFTER SITTING AWHILE. THE SUBJECT HAS NOT HAD SURGERY ON THE KNEE SINCE THE LAST STUDY VISIT/CONTACT. VISIT WAS CONDUCTED REMOTELY, THUS THERE ARE NO RADIOGRAPHS TO PROVIDE, OR PHYSICAL EXAM NOTES FROM PI.

  Patient problems: Insufficient Information

  MAUDE report 24093314 ↗
• InjuryJan 13, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  ALL POLY TIBIA STUDY: AS NOTED ON THE 6YR VISIT OF THE FOLLOW-UP QUESTIONNAIRE (COLLECTED OVER THE PHONE), THE SUBJECT NOTED YES AND NO TO THEIR SATISFACTION WITH THE RIGHT KNEE REPLACEMENT. THE SURGERY FIXED THE PAIN AND ALLOWED TO WALK, BUT THE ENTIRE PROCESS HAS NOT MET EXPECTATIONS. THE PATIENT IS HAVING DIFFICULTY WALKING DUE TO STIFFNESS. THE SUBJECT HAS NOT HAD SURGERY ON THE KNEE SINCE THE LAST STUDY VISIT/CONTACT.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 21144262 ↗