Triathlon 5549-A-251Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327000733), received between Jul 9, 2024 and Jul 9, 2024 — classified as 1 injury.

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.

• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS TO COVER THE REVISION THAT OCCURRED ON (B)(6) 2023 DUE TO PATELLA TENDON RUPTURE. PATIENT NOTED THAT THEY HAD TO GO BACK AND REATTACH SOFT TISSUE ON HIS PATELLA, ALSO REPLACED SCR SYNTHETIC SHAFT, HINGE PIN FEMUR, AND HINGE LPS. PATIENT LEFT VOICE MAIL ON PATIENT VOICE LINE INDICATING POSSIBLE BREAKAGE OF STRYKER IMPLANT. PATIENT NOTED IMPLANTATION ON (B)(6) 2023. ADDITIONAL INFO: IMPLANT FAILURE. PHYSICIAN STATED A FAILED JUNCTION CAUSING THE FEMUR STEM TO ROTATE AND DISLOCATE AND HE HAS TO PUSH IT BACK AND IT SHOULD NOT. HAD A KNEE INFECTION WHICH RESULTED IN HIM HAVING INITIAL KNEE IMPLANTS. ALSO HAS COMPETITOR IMPLANTS. ADDITIONAL INFO: I HAD A CT SCAN DONE WITH THIS FINDING: EXTERNAL ROTATION OF THE DISTAL FEMORAL COMPONENT RELATIVE TO THE FEMORAL NECK, 46.2 DEGREES.

  Patient problems: Muscle/Tendon Damage; Pain; Rupture

  MAUDE report 19706664 ↗