Triathlon 5537-G-631Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327027457), received between Sep 20, 2018 and Oct 10, 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 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED BY REP: "PATIENT IS MENTALLY UNSTABLE AND JUMPED OFF A BALCONY, TEARING HIS RETINACULUM. DOCTOR WASHED WOUND AND SWAPPED OUT TS LINER FOR A BRAND NEW ONE". REP ALSO REPORTED THERE WERE NO ALLEGATIONS AGAINST THE LINER.

  Patient problems: Injury; Tissue Damage

  MAUDE report 7953936 ↗
• InjurySep 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO POSSIBLE INFECTION (POSSIBLE CAUSE OF INFECTION, CLINICAL CONFIRMATION NOT REPORTED). AN I&D WITH POLY SWAP (SAME CATALOG NUMBER) WAS PERFORMED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7894643 ↗