Triathlon 5565-S-018Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327026818), received between Aug 15, 2018 and Aug 1, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Fracture” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO THE THREADED PORTION OF THE FLUTED STEM BREAKING AT THE FEMORAL COMPONENT INTERFACE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Discomfort

  MAUDE report 17439036 ↗
• InjuryMar 22, 2022Fracture; Detachment of Device or Device Component; Device Dislodged or Dislocated; Fracture; Detachment of Device or Device Component; Device Dislodged or Dislocated

  STEM DISASSOCIATED FROM THE RIGHT FEMORAL COMPONENT. REQUIRED REVISION SURGERY. NO ALLEGATIONS AGAINST THE INSERT OR AUGMENT.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 13845064 ↗
• InjuryMay 18, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO ASEPTIC FEMORAL LOOSENING. POSSIBLE CAUSE OR CONTRIBUTOR FOR LOOSENING WAS NOT REPORTED TO THE REP. THE PATIENT'S FEMORAL COMPONENT, STEM, AUGMENTS, AND INSERT WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT. REP ALSO PROVIDED THE USAGE SHEET FROM THE PRIOR SURGERY, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10066288 ↗
• InjuryOct 2, 2018Migration; Migration

  IT WAS REPORTED PATIENT'S RIGHT KNEE WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENTS. A SIZE 4 FEMORAL COMPONENT ALONG WITH A PRESS-FIT STEM WHICH WAS CEMENTED IN (MANUFACTURER OF CEMENT UNKNOWN) ALONG WITH A SIZE 7 28MM INSERT WERE REMOVED.

  Patient problems: Injury

  MAUDE report 7927306 ↗
• InjuryAug 15, 2018Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO A LOOSE TIBIA. A BASEPLATE, PS INSERT, 2 AUGMENTS, OFFSET, AND STEM WERE REVISED TO A TS CONSTRUCT WITH 3 AUGMENTS.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7786014 ↗