Triathlon 5516-F-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327040845), received between Dec 23, 2019 and Apr 20, 2022 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2022Unstable; Unstable

  PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "ALWAYS PUTTING LIDOCAINE ON EVERY NIGHT TO GET TO SLEEP. NOT MUCH PAIN. HAVE FALLEN NUMEROUS TIMES. ALWAYS NERVOUS WALKING. KNEE STILL GIVES OUT, JUST FEELS TOO LOOSE."

  Patient problems: Fall; Joint Laxity; Pain

  MAUDE report 14161032 ↗
• InjuryDec 23, 2019Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT AND INSTABILITY. THE FEMORAL COMPONENT AND INSERT WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9512565 ↗