Triathlon 5537-G-519Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327027334), received between Aug 20, 2018 and Apr 8, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryApr 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT WITH A POLY SWAP OF THE SAME CATALOG NUMBER.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8491086 ↗
• InjuryAug 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT IS A SUBJECT IN STRYKER'S TRIATHLON TRITANIUM CONE AUGMENTS OUTCOMES STUDY. ACCORDING TO THE HOSPITAL: "THE PATIENT STARTED TO DEVELOP SWELLING AND PAIN IN THE LEFT KNEE ON THE FIRST WEEK OF (B)(6) 2018. THERE WAS NO ASSOCIATED CAUSATIVE EVENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2018 AND UNDERWENT IRRIGATION AND DEBRIDEMENT ON (B)(6) 2018 TO TREAT THE INFECTION THAT WAS DIAGNOSED." THE TIBIAL INSERT WAS EXPLANTED (B)(6) 2018.

  Patient problems: Injury; Pain; Swelling; Unspecified Infection

  MAUDE report 7798169 ↗