Triathlon 5537-G-513Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327027310), received between Oct 23, 2019 and Dec 11, 2023 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE REVISION ON (B)(6) 2022. AS REPORTED: "PATIENT IS STATUS POST RIGHT KNEE REVISION DUE TO INFECTION. EXPLANTS ARE INCLUDED ON ORIGINAL USAGE SHEET. ALL WERE REMOVED EXCEPT FOR SIZE 5/13 TS INSERT WHICH WAS REMOVED ON (B)(6) 2022,

  Patient problems: Unspecified Infection

  MAUDE report 18300396 ↗
• InjuryFeb 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REPORTED. AS REPORTED BY REP: "PT. PRESENTED WITH COMPLAINTS OF KNEE-PAIN, DR. SUSPECTED ASEPTIC-LOOSENING AND PERFORMED A REVISION OF THE PT'S LEFT-TKA. THE PT. HAD BEEN REVISED PREVIOUSLY IN 2017. EXPLANTED ALL DEVICES. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES."

  Patient problems: Pain

  MAUDE report 16302006 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. A 5X13 TS INSERT WAS REVISED TO A 5X16 TS INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 15204386 ↗
• InjuryNov 15, 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 13236 KNEE. 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 12813345 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "DOCTOR PERFORMED A RIGHT KNEE REVISION ON (B)(6) 2020. ORIGINAL DATE OF TS SURGERY (B)(6) 2017. REASON FOR REVISION IS INFECTION...NO MORE INFORMATION IS AVAILABLE PER DOCTOR." REP PROVIDED THE PRIMARY IMPLANT SHEET. A 5X13 TS INSERT WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 11129636 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY ON (B)(6) 2019. PATIENT HAD LEFT KNEE PERIPROSTHETIC JOINT INFECTION. THEN PATIENT UNDERWENT ONE STAGE LEFT TOTAL KNEE REVISION ON (B)(6) 2020. ALL COMPONENTS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 11107243 ↗
• InjuryOct 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT REQUIRED AN I&D WITH INSERT REPLACEMENT DUE TO INFECTION FOR A REV TKA WHICH WAS PERFORMED ON (B)(6) 2019. A SIZE 5 X 13MM TS INSERT WAS EXPLANTED AND A NEW SIZE 5 X 13MM TS INSERT WAS IMPLANTED. PATIENT IS (B)(6) AND IS IMMUNOCOMPROMISED.

  Patient problems: Unspecified Infection

  MAUDE report 9226588 ↗