Triathlon 5537-G-609Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327027389), received between Apr 26, 2017 and May 27, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: THE IMPLANT WAS PLACED IN 2025 FOR KNEE PROSTHESIS REVISION FOLLOWING A PERIPROSTHETIC INFECTION. ON (B)(6) 2026, A TWO-STAGE REVISION PROCEDURE WAS PERFORMED DUE TO SUSPECTED INFECTION OF THE RIGHT KNEE PROSTHESIS, WITH IMPLANTATION OF A CEMENT SPACER (TWO-STAGE RIGHT TKA REVISION). THE REPORT INVOLVES THE ENTIRE KNEE PROSTHESIS SYSTEM, INCLUDING: 1- FEMORAL COMPONENT, 2- FEMORAL STEM, 3 - TIBIAL COMPONENT, 4 - TIBIAL STEM, 5- TIBIAL INSERT WITH POST, 6¿7 FEMORAL AUGMENTS. IMPLANTATION DATE: THE EXACT DAY IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25304281 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTED. A 6X9 TS POLY WAS SWAPPED FOR ANOTHER OF THE SAME TYPE AND SIZE AND A WASH OUT WAS DONE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 13419669 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED DUE TO SUSPECTED INFECTION. A 6X9 TS POLY WAS EXCHANGED FOR ANOTHER 6X9 TS POLY AND A WASHOUT WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 12907214 ↗
• InjuryApr 26, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED RIGHT KNEE REVISION DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6524646 ↗