Triathlon 5542-A-602Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327015430), received between Aug 26, 2019 and Aug 26, 2019 — classified as 2 injuries.

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

• InjuryAug 26, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FEMORAL COMPONENT LOOSENING. THE PATIENT'S ENTIRE KNEE CONSTRUCT (FEMORAL COMPONENT, STEM, AUGMENTS, INSERT, TIBIAL BASEPLATE WITH STEM) WERE REVISED TO A DISTAL FEMORAL REPLACEMENT DUE TO THE PATIENT'S POOR BONE QUALITY. NO ALLEGATIONS AGAINST THE TIBIAL BASEPLATE OR LINER WERE REPORTED TO THE REP. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8930832 ↗
• InjuryAug 26, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FEMORAL COMPONENT LOOSENING. THE PATIENT'S ENTIRE KNEE CONSTRUCT (FEMORAL COMPONENT, STEM, AUGMENTS, INSERT, TIBIAL BASEPLATE WITH STEM) WERE REVISED TO A DISTAL FEMORAL REPLACEMENT DUE TO THE PATIENT'S POOR BONE QUALITY. NO ALLEGATIONS AGAINST THE TIBIAL BASEPLATE OR LINER WERE REPORTED TO THE REP. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8930831 ↗