Triathlon 5542-A-601Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327015423), received between May 18, 2020 and May 18, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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.

• InjuryMay 18, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO ASEPTIC FEMORAL LOOSENING. POSSIBLE CAUSE OR CONTRIBUTOR FOR LOOSENING WAS NOT REPORTED TO THE REP. THE PATIENT'S FEMORAL COMPONENT, STEM, AUGMENTS, AND INSERT WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT. REP ALSO PROVIDED THE USAGE SHEET FROM THE PRIOR SURGERY, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10067141 ↗
• InjuryMay 18, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO ASEPTIC FEMORAL LOOSENING. POSSIBLE CAUSE OR CONTRIBUTOR FOR LOOSENING WAS NOT REPORTED TO THE REP. THE PATIENT'S FEMORAL COMPONENT, STEM, AUGMENTS, AND INSERT WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT. REP ALSO PROVIDED THE USAGE SHEET FROM THE PRIOR SURGERY, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10067132 ↗