Triathlon 5546-A-301Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327026436), received between Jun 29, 2018 and Jan 21, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 21, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED: "PATIENT'S LEFT TIBIAL COMPONENT WAS REVISED DUE TO LOOSENING¿ALL TIBIAL COMPONENTS (12X50 STEM, SIZE 3 UNIVERSAL BASEPLATE, TWO AUGMENTS, 3X16 TS INSERT)¿WERE EXPLANTED AND REVISED TO TRIATHLON TS. TIBIAL SIDE AS A WHOLE WAS LOOSENED, NO SPECIFIC IMPLANT(S) CITED."

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8265295 ↗
• InjuryJun 29, 2018Mechanical Problem; Loss of Osseointegration; Mechanical Problem; Loss of Osseointegration

  AS REPORTED: "THIS IS A STUDY SUBJECT ON THE STRYKER SPONSORED STUDY TRIATHLON TS REVISION STUDY. THE STUDY COORDINATOR SENT IN AN ADVERSE EVENT FORM NOTING THAT THE SUBJECT EXPERIENCED FEMORAL AND TIBIAL COMPONENT LOOSENING AND UNDERWENT A REVISION ON (B)(6) 2018."

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7652511 ↗