Triathlon 5510-F-201Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327040234), received between Dec 11, 2017 and Apr 24, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT A CEMENTED FEMORAL COMPONENT WAS IMPLANTED IN A KNEE THAT WAS PREPPED FOR PRESS-FIT. DISCOVERY WAS MADE 1 WEEK POST-OP WHEN REVIEWING INVENTORY. THE FEMORAL COMPONENT WAS REVISED TO A PRESS-FIT FEMORAL COMPONENT.

  Patient problems: Insufficient Information

  MAUDE report 21898647 ↗
• InjuryMay 3, 2023Use of Device Problem; Use of Device Problem

  IN MAKO TKA SURGERY, A FEMORAL CEMENTING IMPLANT WAS USED WITHOUT CEMENT TO A PATIENT WHO WAS SCHEDULED TO HAVE A FEMORAL CEMENTLESS IMPLANT. AFTER THE PATIENT LEFT THE OPERATING ROOM, THE EVENT WAS DISCOVERED, AND THE SURGEON DECIDED TO RETURN THE PATIENT TO THE OPERATING ROOM FOR A REVISION SURGERY TO REPLACE IT WITH A CEMENTLESS IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 16858431 ↗
• InjuryFeb 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PERIPROSTHETIC FRACTURE. PATIENT CONVERTED TO GMRS. OPERATIVE SIDE IS LEFT. UPDATE: PER RECEIVED RESPONSE, THE PATIENT'S FEMUR WAS FRACTURED.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 9757876 ↗
• InjuryDec 11, 2017Off-Label Use; Off-Label Use

  AS REPORTED BY REP, WHO WAS NOT PRESENT FOR THE EVENT: ¿IN PERFORMING A LEFT TKR, SURGEON REQUESTED A PRESS-FIT FEMUR. THE ASSOCIATE REP WHO WAS PRESENT TOOK A CEMENTED FEMUR, CONFIRMED IT WITH THE O.R. STAFF TWICE, AND SHOWED IT TO THE SURGEON. SURGEON IMPLANTED THE CEMENTED FEMUR WITHOUT CEMENT. UPON SUBMITTING THE BILLING SHEET TO THE REP, REP DISCOVERED A PRESS-FIT BASEPLATE USED WITH A CEMENTED FEMUR AND CONTACTED THE ASSOCIATE REP TO TRY TO GET THE CORRECT IMPLANT IMPLANTED. PATIENT HAD BEEN BROUGHT OUT OF THE O.R. AND WAS AWAKE. THE SURGEON EXPLAINED TO THE PATIENT WHAT HAD HAPPENED. PATIENT WAS BROUGHT BACK INTO THE O.R. AND THE CEMENTED FEMUR WAS REVISED TO A PRESS-FIT FEMUR.

  Patient problems: Injury

  MAUDE report 7105853 ↗