Triathlon 5531-G-513-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327336719), received between Nov 14, 2021 and Sep 9, 2025 — classified as 6 injuries.

7 other recalls cover devices cleared under the same FDA submission (K172634); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I&D OF A LEFT KNEE TRIATHLON FOR INFECTION. A TIBIAL INSERT CHANGE WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 23001790 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A BILATERAL INDEX TKA ON (B)(6) 2023. PATIENT PRESENTED WITH PJI ON THE LEFT KNEE, (B)(6) 2024. ALL COMPONENTS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 22580493 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO SUSPECTED INFECTION. AN I&D AND WASHOUT WAS PERFORMED, AND A 5X13 CS INSERT WAS REVISED TO A 5X11 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 20195665 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD BILATERAL INDEX TKA. 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) 2021FOR AN I&D AND POLY EXCHANGE REPORTED. PATIENT RETURNS WITH PERSISTENT PJI, UNDERGOES NEW REVISION WITH AN I&D AND A POLY EXCHANGE ONLY. PATIENT RETURNS WITH PERSISTENT PJI, UNDERGOES ANOTHER REVISION WITH AN I&D AND A POLY EXCHANGE ONLY. PATIENT RETURNS WITH PERSISTENT PJI AND IS REVISED ON (B)(6) 2021. ALL COMPONENTS WERE EXCHANGED EXCEPT PATELLA.

  Patient problems: Unspecified Infection

  MAUDE report 13618857 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PAINFUL KNEE WITH SUPERFICIAL WOUND INFECTION. REVISION SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 13564016 ↗
• InjuryNov 14, 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 FEBRUARY (B)(6) 2021 WITH PERSISTENT PJI, UNDERGOES ANOTHER REVISION WITH AN I&D AND A POLY EXCHANGE ONLY.

  Patient problems: Unspecified Infection

  MAUDE report 12808415 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172634. One submission often covers many models, so check the product and lot details in each record.

• Z-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1265-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 MM
• Z-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1654-2023 · Apr 13, 2023 · Open, Classified
  TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E