Triathlon 5537-G-622Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327027686), received between Sep 17, 2018 and Oct 15, 2018 — 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.

• InjuryOct 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION (INFECTION REPORTED BY SURGEON, UNKNOWN IF CLINICALLY CONFIRMED, INFECTING MICROORGANISM NOT REPORTED TO REP). SURGEON PERFORMED AN I&D WITH INSERT EXCHANGE. PATIENT WAS REVISED TO A 6X28 TS INSERT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7967383 ↗
• InjurySep 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S RIGHT KNEE WAS REVISED. A 6X22 TS INSERT WAS IMPLANTED. REVISION WAS DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7882682 ↗