Triathlon 5517-F-102Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327040913), received between Apr 22, 2020 and Jul 31, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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.

• InjuryJul 31, 2026Loss of Osseointegration

  The following information was provided: Due to loosening following TKA, all implants were removed and a revision procedure was performed.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration

  MAUDE report 50101873 ↗
• InjuryJun 29, 2026Loss of Osseointegration

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO GROSS INSTABILITY AND TIBIAL SUBSIDENCE. INTRA-OPERATIVELY, THE TIBIAL AND FEMORAL COMPONENTS WERE FOUND TO BE LOOSE. A CR/CS KNEE WAS CONVERTED TO A TS KNEE (PATELLAR COMPONENT WAS RETAINED). THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 25650455 ↗
• InjuryNov 4, 2021Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  A RIGHT-SIDED FEMORAL COMPONENT WAS BROUGHT TO THE O.R. AND O.R. STAFF MADE AWARE. THE RIGHT-SIDED IMPLANT WAS PUT INTO THE PATIENT'S LEFT KNEE. SURGEON DECIDED TO REVISE THE PATIENT'S KNEE 1 DAY POST-OP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751578 ↗
• InjuryApr 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A TIBIAL PERIPROSTHETIC FRACTURE. SURGEON REPORTED PATIENT FACTORS OF POOR BONE QUALITY AND OSTEOPENIA. THE TIBIAL COMPONENT, INSERT AND THE WELL-FIXED FEMUR WERE REVISED TO A LARGER-SIZED TS CONSTRUCT WITH STEMS AND AUGMENTS. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 9986652 ↗