Triathlon 5510-F-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327040241), received between May 29, 2018 and May 27, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Unstable” (3 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Unstable; Use of Device Problem

  No new information.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 25300554 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF R TRIATHLON CR FEMORAL COMPONENT DUE TO PATIENT PAIN. SUCCESSFULLY COMPLETED. NOTIFICATION ONLY.

  Patient problems: Insufficient Information; Pain

  MAUDE report 24979784 ↗
• InjuryMar 7, 2025Use of Device Problem; Use of Device Problem

  REVERSED LEFT AND RIGHT IMPLANTS WERE INSERTED INTO THE PATIENT. IT WAS THE NURSE WHO REMOVED IT FROM THE KIT. SHE SHOWED THE SURGEON THE IMPLANT LABEL BEFORE OPENING THE PACKAGE AND DOUBLE-CHECKED IT, BUT IT SEEMED TO BE A STREAMLINED PROCESS, AND THE SURGEON DIDN'T NOTICE THE LEFT-RIGHT MISTAKE. BECAUSE THE MISTAKE WAS NOTICED A LITTLE OVER 10 MINUTES AFTER THE IMPLANT WAS INSERTED, THE CEMENT HAD ALREADY HARDENED AND THE IMPLANT WAS REMOVED, ALONG WITH THE BONE. THE PATIENT'S BONE WAS THEN GRAFTED AND THE IMPLANT OF THE PLANNED SIZE WAS SECURED WITH CEMENTATION.

  Patient problems: Insufficient Information

  MAUDE report 21545621 ↗
• InjuryFeb 26, 2024Loss of Osseointegration; Loss of Osseointegration

  REVISED A RIGHT TRIATHLON FEMUR AND INSERT DUE TO FEMORAL LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18779483 ↗
• InjuryDec 22, 2020Unstable; Unstable

  PROCEDURE: THE PATIENT UNDERWENT BILATERAL KNEE ARTHROPLASTY (B)(6) 2015. PATIENT HAD RIGHT KNEE PAIN AND INSTABILITY FOR MORE THAN TWO YEARS. THEN PATIENT UNDERWENT RIGHT TOTAL KNEE REVISION ON (B)(6) 2020. ALL COMPONENTS EXCHANGED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11055293 ↗
• InjuryNov 10, 2020Material Erosion; Insufficient Device Problem Information; Material Erosion; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT FELL ON OR ABOUT (B)(6) 2020 AND THEIR RIGHT KNEE WAS REVISED. A CS TIBIAL BEARING INSERT AND CR FEMORAL COMPONENT WERE REVISED TO A CEMENTED PS FEMORAL COMPONENT, SIZE 2 TRIATHLON TS PLUS X3 POLY, AND MODULAR DISTAL FEMORAL FIXATION PEG. SPOKE TO REP: POSTERIOR INSERT WEAR WAS NOTED INTRA-OPERATIVELY. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall

  MAUDE report 10815575 ↗
• InjuryOct 21, 2019Unstable; Unstable

  REVISION OF TRIATHLON KNEE DUE TO INSTABILITY AND SUSPECTED POLY WEAR.

  Patient problems: Injury

  MAUDE report 9213437 ↗
• InjuryMay 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF AN IMPLANT SHEET THAT ON (B)(6) 2018, PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. REVISION IMPLANTS INCLUDED A FEMORAL COMPONENT, A TIBIAL INSERT, ONE EACH OF FLUTED AND CEMENTED STEMS, TIBIAL BASEPLATE, OFFSET ADAPTER, AND THREE AUGMENTS AS WELL AS A PATELLA. THE PRIMARY PROCEDURE WAS A REVISION FROM A COMPETITOR CONSTRUCT - THE ONLY STRYKER IMPLANTS WERE A FEMORAL COMPONENT AND INSERT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7548437 ↗