Triathlon 5530-P-311Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327041736), received between Jul 8, 2019 and Sep 16, 2021 — classified as 2 injuries.

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

• InjurySep 16, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. PATIENT PRESENTED IN SEVERE VARUS DUE TO TIBIAL BASEPLATE LOOSENING. INTRA-OPERATIVELY, IT WAS NOTICED THAT THE INSERT HAD CRACKED MEDIALLY POSTERIORLY.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration

  MAUDE report 12482529 ↗
• InjuryJul 8, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. THE INSERT WAS REVISED. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8767864 ↗