Triathlon 5537-G-409Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327027211), received between Dec 17, 2018 and Mar 13, 2022 — 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.

• InjuryMar 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT LEFT INDEX TKA OUTSIDE CORS SCOPE. PATIENT PRESENTS WITH PAIN AND IS STUDIED FOR INFECTION. SHE IS REVISED FOR PAIN AND TIBIAL LOOSENING ON (B)(6) 2021. ALL COMPONENTS WERE EXCHANGED. PATIENT PERSISTS WITH PAIN AND SIGNS OF INFECTION, SHE IS REVISED AGAIN FOR PJI ON (B)(6) 2021. ONLY POLY WAS EXCHANGED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 13752571 ↗
• InjuryDec 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S LEFT KNEE WAS REVISED. REP NOTE ON THE IMPLANT SHEET INDICATES "PATIENT WAS REVISED FOR STABILITY" A 4X9 TS INSERT WAS IMPLANTED.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8169285 ↗