Triathlon 5535-A-311Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327043532), received between Jan 28, 2025 and Jan 28, 2025 — 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.

• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: "AS NOTED ON THE 4YR VISIT OF THE FOLLOW-UP QUESTIONNAIRE (COLLECTED OVER THE PHONE), THE SUBJECT ANSWERED NO TO HER SATISFACTION WITH THE RESULTS OF THE KNEE REPLACEMENT. THE SUBJECT COMMENTED "OVERALL NOT SATISFIED WITH THE RESULTS" AND "REIKI HELPS, BUT IT ISN'T COVERED THROUGH INSURANCE. MOBILITY IS FINE, BUT IT JUST HURTS." WHEN ASKED ABOUT PAIN, THE SUBJECT STATED "TENDERNESS, ACHINESS ON THE LEFT SIDE OF THE KNEE." THE SUBJECT HAS NOT HAD SURGERY ON THE KNEE SINCE THE LAST STUDY VISIT/CONTACT. ALL VISITS COMPLETED WERE CONDUCTED REMOTELY, THUS THERE ARE NO RADIOGRAPHS TO PROVIDE OR PHYSICAL EXAM NOTES AVAILABLE."

  Patient problems: Pain

  MAUDE report 21253542 ↗