Triathlon 5520-B-700Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327041064), received between Mar 6, 2019 and Feb 24, 2022 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2022Malposition of Device; Malposition of Device

  SOME OF OUR IMPORTANT USERS BELIEVE TRIATHLON IMPLANT HAS TENDENCY TO BE AT VALGUS ALIGNMENT AND SOME OF THEIR CASES HAD THIS PROBLEM. THE DOCTOR ASKED HIS FOLLOWERS TO CUT DISTAL FEMUR AT 3-4 VALGUS DEGREES FOR ALL TRIATHLON CASES. AS HE IS AMONG THE TOP IMPORTANT KOLS FOR US AND HE IS AMONG CORE MEMBERS OF IRAN KNEE SOCIETY, IT IS SO VITAL FOR US TO SOLVE THIS PROBLEM. THE CASES IS NOT ROBOTIC, IT IS MANUAL TKA. UPDATE AS PER MEDICAL REVIEW: "THE FEMORAL COMPONENT IS POSITIONED IN EXCESSIVE VALGUS IN RELATION TO THE LONGITUDINAL AXIS OF THE FEMUR.¿

  Patient problems: Deformity/ Disfigurement

  MAUDE report 13590551 ↗
• MalfunctionDec 11, 2020Device Difficult to Setup or Prepare; Defective Device; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Defective Device; Detachment of Device or Device Component

  AS REPORTED: "BASEPLATE WOULDN'T FULLY ENGAGE ONTO THE BASEPLATE INSERTER." SPOKE TO REP, WHO WAS PRESENT FOR THE PROCEDURE. PRIMARY TKA. A SECOND BASEPLATE WAS OPENED AND ENGAGED ONTO THE SAME INSERTER WITHOUT ISSUE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 1 MINUTE WHILE A TOURNIQUET WAS IN USE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10990220 ↗
• InjuryNov 10, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2017 THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY USING SIMPLEX HV BONE CEMENT. IT IS FURTHER ALLEGED THAT HE WAS REVISED ON (B)(6) 2020 DUE TO ALLEGED LOOSENING OF HIS KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10816693 ↗
• InjuryNov 9, 2020Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2017 THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY USING SIMPLEX HV BONE CEMENT. IT IS FURTHER ALLEGED THAT THE PATIENT WAS REVISED ON (B)(6) 2018 DUE TO ALLEGED LOOSENING OF HIS KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10814574 ↗
• InjuryOct 14, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND LOOSENING. THE REP WAS NOT TOLD WHAT HAD LOOSENED. THE FEMORAL COMPONENT, INSERT, AND BASEPLATE WERE REVISED TO COMPETITOR DEVICES.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 10677191 ↗
• MalfunctionMar 20, 2019Packaging Problem; Packaging Problem

  PRIMARY PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT UPON OPENING THE INNER STERILE BLISTER OF THE DEVICE, WHITE POWDER WAS OBSERVED ON THE DEVICE. SURGEON HAD TOUCHED THE DEVICE PRIOR TO OBSERVATION AND HAD TO RE-GLOVE. ANOTHER DEVICE WAS PROVIDED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF LESS THAN ONE MINUTE. REP REPORTED HE MAY BE ABLE TO OBTAIN THE OPERATIVE REPORT, AND THAT NO OTHER INFORMATION WILL BE PROVIDED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8435926 ↗
• InjuryMar 14, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "ASEPTIC LOOSENING, RIGHT KNEE TIBIAL COMPONENT".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8422417 ↗
• InjuryMar 6, 2019Osseointegration Problem; Osseointegration Problem

  THE FOLLOWING EVENT WAS REPORTED. PATIENT OF DR (B)(6) PRESENTED WITH A LOOSE CEMENTED TIBIAL COMPONENT.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8395083 ↗