Triathlon 5515-F-702Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327040739), received between Feb 7, 2018 and Jul 9, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Component Incompatible” (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 6 most recent of 6 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

  AS REPORTED: "REVISION RTKA. PERIPROSTHETIC FRACTURE DISTAL FEMUR, REVISED TO DFR."

  Patient problems: Bone Fracture(s)

  MAUDE report 17284221 ↗
• InjuryApr 1, 2021Component Incompatible; Component Incompatible

  DURING A TRIATHLON TKA A PS FEM COMPONENT CEMENTED 5515-F-702, WAS OPENED AND IMPLANTED WITHOUT USING CEMENT. THE SURGEON¿S PLAN FOR THIS CASE WAS FOR A PRESS FIT KNEE, IN WHICH A PS FEM COMPONENT - BEADED W/PA SHOULD HAVE BEEN USED. A TITANIUM BASEPLATE AND A TITANIUM METAL BACKED PATELLA WERE CORRECTLY SELECTED AND IMPLANTED. THIS ISSUE WAS IDENTIFIED AFTER THE BILLING WAS DONE FOR THE CASE AND IT WAS NOTICED ON THE INVOICE THAT A CEMENTED PS FEM COMPONENT WAS IMPLANTED. THIS IDENTIFICATION OCCURRED AFTER THE MEDICAL PROCEDURE. SURGEON HAS PLANNED TO TAKE THE PATIENT BACK TO SURGERY TO REPLACE THE TKA CEMENTED FEMORAL COMPONENT WITH A PRESS FIT FEMORAL COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11601079 ↗
• InjuryJun 4, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED AFTER PATIENT PRESENTED WITH A COMPLAINT IN (B)(6) 2018 (NATURE OF THE COMPLAINT NOT REPORTED TO REP). INTRA-OPERATIVELY, THE TIP OF THE DEVICE WAS BROKEN OFF AND ONE SIDE WAS WORN. UPDATE PER REVISION OPERATIVE REPORT: "MECHANICAL COMPROMISE OF RIGHT TOTAL KNEE ARTHROPLASTY WITH ASSOCIATED FLEXION INSTABILITY (PLY WEAR OF TIBIAL POLY INSERT) PLUS FRACTURE OF TIBIAL POLY INSERT POST...REVISION TOTAL KNEE ARTHROPLASTY (TIBIAL POLY EXCHANGE) WITH REMOVAL OF LOOSE BODY, LYSIS OF ADHESIONS, AND PARTIAL SYNOVECTOMY."

  Patient problems: Injury

  MAUDE report 8666694 ↗
• MalfunctionDec 28, 2018Packaging Problem; Packaging Problem

  DUE TO OPERATIONS MISHANDLING OF THE IMPLANTS, THE OUTER PACKAGE (PACKAGE HAD BEEN WRAPPED TOO TIGHT, AND HANDLED TOO MANY TIMES - CAUSING THE INNER PACKAGE TO BREAK WITHIN THE CARDBOARD BOX). THE NURSE ALONG WITH THE SURGEON DEEMED THE IMPLANT UNSTERILE AND NOT USABLE FOR THE CASE. I REPORTED TO OPERATIONS AND MY OFFICE RIGHT AWAY, BUT DUE TO THE STICKER OF THE IMPLANT IN QUESTION BEING REPORTED ON A BILL SHEET - THE OFFICE INFORMED ME THAT A REPORT MUST BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8203043 ↗
• MalfunctionNov 1, 2018Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem; Tear, Rip or Hole in Device Packaging; Contamination /Decontamination Problem

  FAULTY PACKAGING OF TRIATHLON PROSTHESIS. INNER CONTAINER WAS CRACKED AND STERILITY OF ITEM WAS COMPROMISED. ITEM COULD NOT BE USED FOR SURGERY. ANOTHER ITEM WAS SOURCED AND USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8030708 ↗
• InjuryFeb 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT HAD FLEXION CONTRACTURE AND SOME LIMITED MOTION. REMOVED FEMORAL COMPONENT AND DOWNSIZED TO SIZE 6 FEMUR AND REMOVED SCAR TISSUE AND IMPLANTED STEM AND NEW POLY." OPERATIVE SIDE: RIGHT.

  Patient problems: Injury; Loss of Range of Motion; Scar Tissue

  MAUDE report 7247461 ↗