Triathlon 5532-P-516Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327042825), received between Jul 22, 2022 and Aug 10, 2022 — classified as 2 injuries.

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.

• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT KNEE DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED.

  Patient problems: Unspecified Infection

  MAUDE report 15203666 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN REPORTING A STAGE 1 REVISION OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2022 DUE TO INFECTION, REP PROVIDED A USAGE SHEET FOR A POLY EXCHANGE PERFORMED ON (B)(6) 2022 DUE TO INFECTION. THIS REPORT IS FOR THE (B)(6) 2022 REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 15084938 ↗