Triathlon 5516-F-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327040807), received between Nov 26, 2018 and Nov 26, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Noise, Audible” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2018Noise, Audible; Noise, Audible

  AS REPORTED THROUGH MW5078695 "PATIENT REPORTS SHE WAS UNABLE TO GET UP FROM HER BED ONE MORNING DUE TO SEVERE PAIN IN HER KNEE. SHE REPORTS HEARING CLICKS WHILE WALKING AND HAS EXPERIENCED WEAKNESS, SWELLING AND BUCKLING. HER ORTHOPEDIC SURGEON SAW "SOMETHING STICKING OUT OF HER BONE" AND MENTIONED THAT "SOMETHING PULLS AWAY" WHEN SHE MOVES HER KNEE. PATIENT IS WORRIED HER IMPLANT MAY HAVE BEEN RECALLED. THE PATIENT IS WEARING A KNEE BRACE FOR SUPPORT AND CAN NO LONGER HEAR THE CLICKING NOISE; HOWEVER, HER OTHER SYMPTOMS PERSIST". UPDATE: RIGHT KNEE LOOSENING.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling

  MAUDE report 8104391 ↗