Triathlon 5534-A-409Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327043259), received between Dec 18, 2018 and Nov 25, 2025 — classified as 1 death, 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS FOR THE IRRIGATION AND DEBRIDEMENT (NO REVISION). LEFT KNEE. SUBJECT WAS ENROLLED IN STUDY. SUBJECT CONTACTED SITE BY PHONE TO REPORT SUDDEN ONSET OF PAIN; CLINIC VISIT ASPIRATION WAS POSITIVE FOR STAPH EPIDERMIDIS AND SUBJECT WAS TAKEN TO OR FOR I/D AND START OF LONG-TERM ANTIBIOTIC THERAPY RECEIVING ANCEF, VANCOMYCIN AND DOXYCYCLINE. SUBJECT REPORTED PAIN AND JOINT WAS ASPIRATED. CULTURE WAS POSITIVE FOR DOXYCYCLINE RESISTANT STRAIN OF STAPH AND TAKEN TO SURGERY FOR REVISION. DURING THIS HOSPITALIZATION SUBJECT HAD COMPLICATIONS OF CIRCULATORY SHOCK, ACUTE KIDNEY INJURY AND LIVER FAILURE RESULTING IN DEATH.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 23644438 ↗
• DeathNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE REVISION AND SUBSEQUENT PATIENT DEATH. LEFT KNEE. SUBJECT WAS ENROLLED IN THE STUDY. SUBJECT CONTACTED SITE BY PHONE TO REPORT SUDDEN ONSET OF PAIN; CLINIC VISIT ASPIRATION WAS POSITIVE FOR STAPH EPIDERMIDIS AND SUBJECT WAS TAKEN TO OR FOR I/D AND START OF LONG-TERM ANTIBIOTIC THERAPY RECEIVING ANCEF, VANCOMYCIN AND DOXYCYCLINE. SUBJECT REPORTED PAIN AND JOINT WAS ASPIRATED. CULTURE WAS POSITIVE FOR DOXYCYCLINE RESISTANT STRAIN OF STAPH AND TAKEN TO SURGERY FOR REVISION. DURING THIS HOSPITALIZATION SUBJECT HAD COMPLICATIONS OF CIRCULATORY SHOCK, ACUTE KIDNEY INJURY AND LIVER FAILURE RESULTING IN DEATH.

  Patient problems: Toxic Shock Syndrome; Unspecified Infection

  MAUDE report 23617278 ↗
• InjurySep 9, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 23000675 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT IS PART OF THE TRIATHLON ALL-POLYETHYLENE TIBIA RETROSPECTIVELY ENROLLED AND PROSPECTIVELY FOLLOWED CLINICAL STUDY. DURING THE FOLLOW-UP QUESTIONNAIRE BETWEEN THE PATIENT AND THE STUDY COORDINATOR TO COLLECT INFORMATION ABOUT THE KNEE FOR THE STUDY, THE PATIENT REPORTED MILD PAIN. THE PATIENT STATES THEY HAVE PAIN "ONCE IN A WHILE" AND IT IS "MILD. THE STUDY COORDINATOR COMMENTS THAT THE PATIENT REPORTS MILD PAIN OCCASIONALLY, BUT DOES NOT FEEL IT IS A PROBLEM. NO CLINIC EVALUATION BY THE SURGEON WAS DONE AT THIS TIME. THIS IS ALL THE INFORMATION THE SITE CAN PROVIDE.

  Patient problems: Pain

  MAUDE report 16917907 ↗
• InjuryDec 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S LEFT KNEE WAS REVISED. COMPARING THE REVISION IMPLANT SHEET WITH PATIENT'S PREVIOUS REVISION IMPLANT SHEET, A 4X9 CS ALL POLY TIBIAL COMPONENT AND SIZE 4 CR CEMENTED FEMORAL COMPONENT WERE REVISED TO A 4X11 CS ALL POLY TIBIAL COMPONENT AND ANOTHER SIZE 4 CR CEMENTED FEMORAL COMPONENT. NEITHER IMPLANT SHEET INDICATES WHETHER STRYKER CEMENT WAS USED.

  Patient problems: Injury

  MAUDE report 8174320 ↗