Triathlon 5545-A-402Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327026115), received between Sep 10, 2019 and Feb 18, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• 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 MEDICAL BILLS AND REVISION SURGERY. PATIENT IS SEEKING COMPENSATION. THIS PI IS FOR PAIN AND CRACK/FRACTURE AFTER REVISION. UPDATE: "NEW SURGERY THAT HAPPENED (B)(6), TO REPLACE THE CRACKED PROSTHETIC." UPDATE 03/FEB/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 13563850 ↗
• InjurySep 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND LOSS OF FUNCTION. INTRA- OPERATIVELY, THE FOLLOWING WAS NOTED: THE SIZE 5 CEMENTED FEMORAL COMPONENT WAS LOOSE; THERE WAS A FRACTURE AT THE JUNCTION OF THE FEMORAL STEM AND 12X100 STEM; THE CEMENTED TIBIAL COMPONENT WAS LOOSE; THE JUNCTION OF THE STEM EXTENDER AND 12X50 STEM ON THE TIBIAL SIDE WAS LOOSE. THE PATIENT'S ENTIRE TS KNEE CONSTRUCT (INCLUDING FIVE AUGMENTS) WAS REVISED TO A TRIATHLON TS KNEE CONSTRUCT WITH A CONE. REP PROVIDED ONE PAGE OF THE PRIMARY OPERATIVE REPORT, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8981455 ↗