Triathlon 5515-F-601Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327050417), received between Feb 16, 2018 and Nov 12, 2024 — classified as 4 injuries.

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

• InjuryNov 12, 2024Loss of Osseointegration; Loss of Osseointegration

  THIS PI IS FOR THE LEFT KNEE. AS REPORTED: "DR. IS ASKING FOR US TO DOCUMENT AN INSTANCE OF ASEPTIC LOOSENING FOR A PATIENT SHE OPERATED ON (B)(6) 2022. THE PATIENT HAD BILATERAL TKA AND IS NOW BEING REVISED ON BOTH SIDES FOR LOOSENING. SHE HAD SHARED THE IMPLANT INFORMATION AND ASKED THAT WE CHECK THE LOT NUMBERS FOR ANY RECALLS." NONE OF THE REPORTED IMPLANTS WERE SUBJECT TO RECALL.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20667714 ↗
• InjuryOct 19, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. THE SURGEON'S INITIAL PLAN WAS TO EXCHANGE THE POLY. HOWEVER, INTRA-OPERATIVELY SURGEON DECIDED KNEE STABILITY WAS STILL INSUFFICIENT, AND REVISED THE PS FEMUR AND INSERT TO A TS FEMUR AND INSERT WITH A STEM. REP PROVIDED THE PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Joint Laxity

  MAUDE report 10695963 ↗
• InjuryMay 21, 2019Unstable; Unstable

  PATIENTS KNEE WAS REVISED FOR FLEXION INSTABILITY. THE FEMORAL COMPONENT AND TIBIAL INSERT WERE REVISED TO CORRECT THE ISSUE. LEFT KNEE

  Patient problems: Injury

  MAUDE report 8627663 ↗
• InjuryFeb 16, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO DISLOCATION OF THE PATELLA. SURGEON ALSO REPORTED THAT THE FEMORAL COMPONENT LOOKED ROTATED AND REVISED THE ENTIRE CONSTRUCT.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7277379 ↗