Triathlon 5565-S-021Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327026825), received between Jun 16, 2022 and Jun 16, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Loss of Osseointegration” (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.

• InjuryJun 16, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED BY REP: "PT. PRESENTED WITH THIGH PAIN, IMAGING WAS INDICATIVE OF A LOOSE FEMORAL IMPLANT FOLLOWING A KNEE-REVISION "BACK IN (B)(6) OF 2017". SURGEON RULED OUT INFECTION AND DETERMINED THE FEMORAL CONSTRUCT WAS ASEPTICALLY LOOSE. HE PERFORMED A REVISION OF THE FEMORAL IMPLANTS, LEAVING THE TIBIAL BASEPLATE AND STEM IN-SITU. NO FURTHER INFORMATION AVAILABLE." SPOKE TO REP. NO WEAR OR DAMAGE WAS NOTED INTRA-OPERATIVELY.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 14723093 ↗