Triathlon 5537-G-509Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327027303), received between Sep 7, 2018 and Nov 14, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryNov 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE REVISION ON (B)(6) 2021. PATIENT HAD BILATERAL INDEX TKA (OUTSIDE OF CORS SCOPE). PATIENT IS ADMITTED WITH PAIN AND BILATERAL KNEE PJI. UNDERGOES BILATERAL REVISION ON (B)(6) 2021 WITH ALL COMPONENTS EXCHANGED, AND ANTIBIOTIC LOADED CEMENT FOR TREATMENT. PATIENT RETURNS FOR PERSISTENT RIGHT KNEE PJI ON (B)(6) 2021 FOR AN I&D AND POLY EXCHANGED REPORTED AS CORS PER 13236KNEE. PATIENT RETURNS WITH PERSISTENT PJI, UNDERGOES NEW REVISION WITH AN I&D AND A POLY EXCHANGE ONLY. REPORTED AS CORS PER 13236(2). PATIENT RETURNS (B)(6) 2021 WITH PERSISTENT PJI, UNDERGOES ANOTHER REVISION WITH AN I&D AND A POLY EXCHANGE ONLY.

  Patient problems: Unspecified Infection

  MAUDE report 12808414 ↗
• InjurySep 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO SUSPECTED INFECTION. A WASHOUT WITH POLY SWAP (SAME CATALOG NUMBER) WAS PERFORMED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7858077 ↗