Triathlon 5532-P-309Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327042658), received between Sep 3, 2019 and Feb 25, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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.

• MalfunctionFeb 25, 2025Difficult to Insert; Device Damaged Prior to Use; Difficult to Insert; Device Damaged Prior to Use

  "THE WIRE ON THE IMPLANT DIDN'T PROPERLY ENGAGE AND THEY WERE NOT ABLE TO USE IT. UNABLE TO INSERT MENISCAL COMPONENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21460306 ↗
• InjuryFeb 20, 2024Unintended Movement; Unintended Movement

  THIS PI IS FOR THE REVISION ON (B)(6) 2024. LEFT TOTAL KNEE. AT SOME POINT AFTER THE PRIMARY TOTAL KNEE PROCEDURE THE PATIENT HAD A PERIPROSTHETIC FRACTURE OF THE DISTAL FEMUR. A COMPETITOR RETROGRADE NAIL WAS PLACED TO ADDRESS THE FRACTURE. THE DISTAL TIP OF THE NAIL IMPINGED ON THE PS POST OF THE TOTAL KNEE INSERT. THIS IMPINGEMENT CAUSE DISCOMFORT. TODAY THE NAIL WAS REMOVED AND A NEW INSERT WAS PLACED.

  Patient problems: Discomfort

  MAUDE report 18737327 ↗
• InjurySep 7, 2021Adverse 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. AS REPORTED: "THE PATIENT PRESENTED WITH A PAINFUL LEFT TOTAL KNEE AND AN ELEVATED WHITE BLOOD CELL COUNT." THE PATIENT'S KNEE CONSTRUCT WAS REVISED. SPOKE TO THE REP, WHO PROVIDED PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 12433909 ↗
• InjurySep 3, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. THERE ARE NO ALLEGATIONS AGAINST ANY OF THE PATIENT'S IMPLANTS. A 3X9 PS INSERT WAS REVISED TO A 3X13 TS INSERT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 8955550 ↗