Triathlon 5534-A-316Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327043235), received between Mar 13, 2020 and Aug 17, 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.

• InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS A (B)(6) YEAR-OLD FEMALE WHO PREVIOUSLY UNDERWENT RIGHT TOTAL KNEE REPLACEMENT - OUTSIDE CORS SCOPE. SHE UNDERWENT REVISION ON (B)(6) 2020 FOR PJI. PATIENT DEVELOPED PJI AND REQUIRED RESECTION AND SPACER PLACEMENT IN (B)(6) 2020. ALL COMPONENTS EXCHANGED. PATIENT UNDERWENT REIMPLANTATION ON (B)(6) 2020.

  Patient problems: Unspecified Infection

  MAUDE report 12329882 ↗
• InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. ALL IMPLANTS WERE EXPLANTED AND REVISED TO TRIATHLON TS. ALL INFORMATION AVAILABLE TO US FROM THE FACILITY IS INCLUDED IN THIS REPORT." REP PROVIDED THE PRIMARY USAGE SHEET.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9829028 ↗