Triathlon 5566-S-017Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327026900), received between Dec 28, 2018 and Apr 16, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED BY REP: "THIS IS A REVISION TO A REVISION DONE ON (B)(6) 2016 [(B)(6) 2016 REVISION WAS OF COMPETITOR DEVICES]... THE CURRENT REVISION WAS DUE TO A SUSPECTED LOOSE FEMORAL COMPONENT, AS STATED BY SURGEON". A SIZE 4 TS FEMORAL COMPONENT WITH STEM AND AUGMENTS, AND A TS INSERT WERE REVISED TO ANOTHER SIZE 3 TS FEMORAL COMPONENT WITH STEM AND STEM EXTENDER, AUGMENTS, AND ANOTHER TS INSERT. REP PROVIDED IMPLANT SHEETS FROM CURRENT AND PREVIOUS REVISION, PRE-REVISION X-RAYS, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8520731 ↗
• InjuryDec 28, 2018Inadequacy of Device Shape and/or Size; Unstable; Loss of Osseointegration; Malposition of Device; Inadequacy of Device Shape and/or Size; Unstable; Loss of Osseointegration; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. PRE-OPERATIVE DIAGNOSIS WAS FAILED TOTAL KNEE ARTHROPLASTY. SURGEON COMMENTED THAT HE THOUGHT THE FEMUR WAS NOT CEMENTED ENOUGH FOR PROPER FIXATION TO OCCUR.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8202605 ↗