Triathlon 5534-A-416Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327043280), received between Nov 14, 2021 and Aug 26, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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.

• InjuryAug 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN INDEX LEFT TKA OUTSIDE OF CORS SCOPE. THE PATIENT DEVELOPED PJI IN THE LEFT KNEE AND UNDERWENT REVISION FOR PJI WITH ALL COMPONENTS EXCHANGED ON (B)(6) 2021 (THEN INCLUDED INTO CORS). THE PATIENT DEVELOPED AGAIN PJI AND WAS REVISED WITH ALL COMPONENTS EXCHANGED ON (B)(6), 2021.

  Patient problems: Unspecified Infection

  MAUDE report 15301127 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  CORRECTION: THIS EVENT WAS REPORTED IN ERROR. THIS PI REPORTS THE REMOVAL OF A TEMPORARY SPACER (STAGE 2). THE REVISION FOR INFECTION INVOLVED DEVICES OF AN UNKNOWN MANUFACTURER. INSUFFICIENT INFORMATION WAS PROVIDED AND NO ADDITIONAL INFORMATION IS AVAILABLE, THEREFORE, THIS COMPLAINT IS BEING CANCELED. PATIENT HAD BILATERAL INDEX TKA (OUTSIDE OF CORS SCOPE (B)(6) 2011). HAD A PJI OF BOTH KNEES. UNDERGOES REVISION ON (B)(6) 2020 WITH ALL COMPONENTS EXCHANGED, AND ANTIBIOTIC CEMENT LOADED FOR TREATMENT. PATIENT RETURNS FOR A RIGHT PJI KNEE REVISION ON (B)(6) 2021. ALL COMPONENTS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 12817735 ↗
• InjuryNov 14, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT HAD BILATERAL INDEX TKA (OUTSIDE OF CORS SCOPE (B)(6) 2011). HAD A PJI OF BOTH KNEES. UNDERGOES REVISION ON (B)(6) 2020 WITH ALL COMPONENTS EXCHANGED, AND ANTIBIOTIC CEMENT LOADED FOR TREATMENT. PATIENT RETURNS FOR A LEFT PJI KNEE REVISION ON (B)(6) 2021. ALL COMPONENTS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 12808412 ↗