Triathlon 5565-S-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327026252), received between Jun 18, 2020 and Mar 4, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Degraded; Material Erosion; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: THE CUSTOMER REPORTED THAT: "FRACTURE OF THE TIBIAL AND FEMORAL STEMS LESS THAN TWO YEARS AFTER PROSTHESIS PLACEMENT. DURING REVISION SURGERY, FRACTURE OF THE IMPLANTS AND VERY SIGNIFICANT METALLOSIS WITHIN THE KNEE WERE OBSERVED. IMPLANTATION DATE: (B)(6) 2024; DATE OF EXPLANTATION: (B)(6) 2026.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Metal Related Pathology; Osteolysis

  MAUDE report 24511512 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR CONCERN OF TIBIAL MIDSHAFT STRESS FRACTURE. LEFT KNEE. THIS IS A SUBJECT WHO IS ENTERED IN THE 76 - CONES REVISION STUDY WHO DURING THEIR 7-YEAR PHONE FOLLOW UP INDICATED THAT THEY ARE NOT SATISFIED WITH THEIR IMPLANTS; STATES 'NO PAIN, JUST DISCOMFORT, SWOLLEN, STIFF; SHE STATED SHE WAS UNABLE TO BEND IT OVER 90°'; SHE STATED SHE BEEN TRYING TO SOME YOGA AND STRETCHING EXERCISES FOR HER KNEE AND NOTHING GETTING BETTER FOR HER.' REFUSES CLINIC VISIT. (PRIOR HISTORY OF MUA ON (B)(6) 2016 FOLLOWING STUDY SURGERY ON (B)(6) 2016 FOR ARTHROFIBROSIS. CONCERN FOR MIDSHAFT TIBIAL FRACTURE ON (B)(6) 2021). STUDY SITE HAS PROVIDED ALL INFORMATION AVAILABLE.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 21771246 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON THE LEFT KNEE FOR A TIBIA PERIPROSTHETIC FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 16241206 ↗
• InjuryJul 21, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL IMPLANTS. THE PATIENT'S KNEE WAS REVISED TO A GMRS KNEE. REVISING SURGEON REPORTED THE INDEX SURGEON DID NOT USE ENOUGH CEMENT ON THE ORIGINAL IMPLANTS. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. REP ALSO PROVIDED EXPLANT PICTURES AND REVISION USAGE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12201362 ↗
• InjuryMay 21, 2021Material Erosion; Fracture; Material Erosion; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A BROKEN STEM. A 100MM X 15MM TRIATHLON STEM AND SIZE 4 FEMORAL COMPONENT WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Fall; Inadequate Osseointegration; Insufficient Information; Metal Related Pathology; Pain

  MAUDE report 11862916 ↗
• InjuryJun 18, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LOOSENING. REVISING SURGEON REPORTED THAT CAUSE OR CONTRIBUTOR TO LOOSENING WAS DUE TO THE PRIOR SURGEON NOT USING ENOUGH CEMENT. THE PATIENT'S ENTIRE KNEE CONSTRUCT WAS REVISED. REP PROVIDED EXPLANT PICTURES AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10166540 ↗