Triathlon 5530-G-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327045406), received between Oct 20, 2021 and Oct 20, 2021 — 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.

• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT A SIZE 1 INSERT WAS IMPLANTED WITH A SIZE 2 BASEPLATE. SURGEON HAD REPORTED INTRA-OPERATIVELY THAT THE INSERT HAD LOCKED IN. DISCOVERY OF THE INSERT BEING A SIZE 1 WAS MADE THE SAME DAY POST-OPERATIVELY. THE PATIENT WAS RETURNED TO THE O.R. AND THE INSERT WAS REVISED TO A SIZE 2 INSERT. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE LABELLING OF THE SIZE 1 INSERT, OR OF THE DEVICE INSIDE THE PACKAGE. REP ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 12665779 ↗