Triathlon 5537-G-525Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327027365), received between Mar 7, 2019 and Jul 9, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED.

  Patient problems: Unspecified Infection

  MAUDE report 17284222 ↗
• InjuryDec 17, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. A 5X25 TS INSERT WAS REVISED TO A 5X31 TS INSERT. SPOKE TO REP, WHO CONFIRMED THE REASON FOR REVISION WAS INSTABILITY (UNSTABLE KNEE).

  Patient problems: Injury

  MAUDE report 9481584 ↗
• InjuryMar 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "REVISION OF A REVISION ON (B)(6) 2015 [REVISION WAS OF COMPETITOR DEVICES]¿DUE TO POTENTIAL INFECTION". A 5X25 TS INSERT WAS REVISED TO A 5X31 TS INSERT.

  Patient problems: Injury

  MAUDE report 8399934 ↗