Triathlon 5530-P-313Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327041743), received between Feb 26, 2022 and Feb 26, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2022Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. INTRA-OPERATIVELY, THE POSTERIOR ASPECT OF THE MEDIAL CONDYLE OF THE FEMORAL COMPONENT WAS BROKEN FROM THE REST OF THE IMPLANT, RESULTING IN DAMAGE TO THE INSERT. A SIZE 3 CR FEMUR AND SIZE 3 CR INSERT WERE REVISED TO A SIZE 4 TS FEMUR AND ANOTHER INSERT. INCIDENT OCCURRED DURING A REVISION TOTAL KNEE ARTHROPLASTY IN WHICH THE FEMORAL COMPONENT (5510-F-402) WAS FRACTURED AT THE MEDIAL DISTAL SURFACE. AS WELL AS SIGNIFICANT WEAR ON THE MEDIAL BEARING SURFACE OF THE POLYETHYLENE. THE TIBIAL BASEPLATE (5520-B-300) REMAINED WELL-FIXED, THEREFORE WAS NOT REVISED. THE FEMORAL COMPONENT WAS REVISED WITH A RT TS SIZE 4 FEMUR COMPRISED OF A 5MM AUGMENT DISTAL MEDIAL, 5MM AUGMENT POSTERIOR MEDIAL, AND A 15MM X 50MM CEMENTED STEM. THE POLYETHYLENE WAS REVISED WITH A SIZE 3 X 16MM POSTERIOR STABILIZED INSERT.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 13610244 ↗