Triathlon 5545-A-401Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327026153), received between Feb 18, 2022 and Feb 18, 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.

• InjuryFeb 18, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY PATIENT'S WIFE, PATIENT HAD A RIGHT TKA ON 2010 (APPROX). WITHIN A YEAR OF THE SURGERY PATIENT STARTED TO EXPERIENCE PAIN AND SWELLING. THE PATIENT FOLLOWED UP WITH HIS SURGEON AND WAS TOLD HE HAD AN INFECTION AND WAS REVISED ON 2012 (APPROX). THE PATIENT WAS IMPLANTED WITH AN ANTIBIOTIC SPACER AND APPROX 3-5 MONTHS LATER THE PATIENT WAS IMPLANTED. EARLY THIS YEAR THE PATIENT STARTED TO EXPERIENCE PAIN. ON (B)(6), 2021 THE PATIENT FOLLOWED UP WITH HIS SURGEON WHERE AN X-RAY WAS TAKEN AND WAS TOLD THAT HIS IMPLANT WAS CRACKED. THE SURGEON RECOMMENDED REVISION. PATIENT WOULD LIKE SOME ASSISTANCE WITH (B)(6) AND REVISION SURGERY. PATIENT IS SEEKING COMPENSATION. THIS PI IS FOR PAIN AND CRACK/FRACTURE AFTER REVISION. UPDATE: "NEW SURGERY THAT HAPPENED (B)(6) 2021, TO REPLACE THE CRACKED PROSTHETIC." UPDATE (B)(6) 2022: REVIEW OF MEDICAL FILES INDICATED LOOSENING OF BOTH TIBIAL AND FEMORAL COMPONENTS.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Fibrosis; Inflammation; Pain

  MAUDE report 13563853 ↗