Triathlon 5516-F-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327040838), received between Jul 14, 2020 and Jul 8, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2025Unstable; Unstable

  NO NEW INFORMATION.

  Patient problems: Joint Laxity

  MAUDE report 22434618 ↗
• InjuryMay 17, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. SPOKE TO REP: NOTHING WAS NOTED LOOSE OR BROKEN INTRA-OPERATIVELY. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 11832628 ↗
• InjuryMay 5, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. A 5 PS FEMUR AND 5X13 PS INSERT WERE REVISED TO A SIZE 4 TS INSERT WITH STEM AND AUGMENTS, AND A 5X14 PS INSERT. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS, CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 11776015 ↗
• InjuryOct 16, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FEMORAL AND TIBIAL LOOSENING. THE LINER, PS FEMORAL COMPONENT, AND TIBIAL BASEPLATE WERE REVISED TO COMPETITOR DEVICES. THERE ARE NO ALLEGATIONS AGAINST THE LINER. THERE IS NO INFORMATION AVAILABLE ABOUT THE PRIMARY SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10688755 ↗
• InjurySep 22, 2020Loss of Osseointegration; Loss of Osseointegration

  REVISION TOTAL KNEE FOR ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. PATIENT COMPLAINED OF PAIN. REVISION OF RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 10565869 ↗
• InjuryJul 14, 2020Loss of Osseointegration; Loss of Osseointegration

  REVISION RIGHT TOTAL KNEE. FOR ASEPTIC LOOSENING FEMORAL COMPONENT.

  Patient problems: Injury

  MAUDE report 10270083 ↗