Triathlon 5546-A-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327026573), received between Nov 15, 2019 and Nov 15, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Osseointegration 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2019Osseointegration Problem; Osseointegration Problem

  THIS PI IS FOR A SECOND REVISION SURGERY THE PATIENT UNDERWENT ON (B)(6) 2017 DUE TO BASEPLATE/TIBIAL STEM LOOSENING. EXCERPT FROM MEDICAL REVIEW: "LOOSENING OF THE TRIATHLON BASEPLATE WITH ASSOCIATED STEM EXTENDER WAS CONFIRMED WHILE FEMORAL AND PATELLAR COMPONENTS PROVED TO BE WELL FIXED AND WERE AS SUCH RETAINED."... ¿THE USE OF A RELATIVELY SHORT 50-MM STEM EXTENDER BELOW AN AUGMENT IN A PROXIMAL TIBIAL BONE DEFECT CONDITION DID NOT PROVIDE ADEQUATE STABILITY TO THE NEWLY IMPLANTED BASEPLATE DURING THE PREVIOUS REVISION WITH EXCESSIVE MICROMOTION IN THE IMPLANT-BONE INTERFACE RESULTING IN EARLY LOOSENING REQUIRING A SECOND REVISION WITHIN SHORT INTERVAL. "...

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9329143 ↗