Triathlon 5537-G-411Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327027228), received between Feb 22, 2019 and Dec 9, 2024 — 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.

• InjuryDec 9, 2024Mechanical Problem; Mechanical Problem

  SUBJECT HAD A REVISION SURGERY OF COMPETITOR COMPONENTS WITH STRYKER CONE AUGMENTS AS PART OF THE 76 TRIATHLON CONES STUDY. SUBJECT REQUIRED A MANIPULATION UNDER ANESTHESIA FOR LIMITED RANGE OF MOTION WHICH RESOLVED FOLLOWING THE MUA ON (B)(6) 2019.

  Patient problems: Loss of Range of Motion

  MAUDE report 20885506 ↗
• InjurySep 29, 2022Adverse 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. AS REPORTED: "PT. PRESENTED WITH SYMPTOMS OF AN ACUTE KNEE-INFECTION. DR. HERNANDEZ OPTED TO EXPLANT ALL PREVIOUS IMPLANTS AND GIVE THE PATIENT A DYNAMIC ¿SPACER¿ WHICH WOULD ALLOW HER TO BEAR WEIGHT AND ACHIEVE GREATER FUNCTION THAN SHE WOULD WITH A STATIC-SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 15507595 ↗
• InjuryJul 17, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED BY REP: "REVISION OF X3 TS INSERT, DUE TO GLOBAL INSTABILITY." A 4X11 TS INSERT WAS REVISED TO A 4X16 TS INSERT. SPOKE TO REP, WHO CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10288166 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT LEFT KNEE REPLACEMENT IN 2013 OUT OF CORS SCOPE. PATIENT UNDERWENT LEFT TOTAL KNEE REPLACEMENT OF LINER (B)(6) 2017 BY DR. (B)(6). PATIENT HAD LEFT KNEE PERIPROSTHETIC JOINT INFECTION AND ALL COMPONENTS EXCHANGED (B)(6) 2017. UPDATE: ON (B)(6) 2018 THE PATIENT SUFFERS A PPFX OF THE FEMUR (B1) AND RECEIVES AN ORIF. NO COMPONENTS WERE EXCHANGED AT THAT TIME. THIS IS FOR SECOND REVISION DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8361698 ↗