Triathlon 5537-G-319Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327027167), received between Nov 7, 2018 and Feb 25, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A RIGHT TKA OUTSIDE CORS SCOPE IN 2013, REQUIRED AN MUA ONE MONTH LATER. THE PATIENT DEVELOPED PJI WITH MSSA AND LATER WITH MRSA. HAS BEEN REVISED 5 TIMES OUT OF CORS SCOPE. IN (B)(6) 2017 THE PATIENT IS REIMPLANTED, NOW ENTERING CORS REGISTRY. PATIENT DEVELOPS AGAIN PJI AND INSTABILITY. PATIENT UNDERGOES RESECTION AND REVISION ON (B)(6) 2021.

  Patient problems: Bacterial Infection

  MAUDE report 13597575 ↗
• InjuryJan 20, 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 LEFT KNEE DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A SPACER PLACED.

  Patient problems: Unspecified Infection

  MAUDE report 13306610 ↗
• InjuryNov 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S RIGHT KNEE WAS REVISED. A 3X19 TS INSERT WAS REVISED TO A 3X22 INSERT, AND A PATELLA WAS IMPLANTED.

  Patient problems: Injury

  MAUDE report 8045963 ↗