Triathlon 5532-G-509-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327337709), received between Nov 19, 2020 and Nov 21, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025Unstable; Unstable

  PATIENT IS STATUS POST FOR REVISION OF A LTKA COMPLETED TODAY DUE TO INSTABILITY. NO ADDITIONAL DETAILS TO BE REPORTED BY FACILITY.

  Patient problems: Joint Laxity

  MAUDE report 23616272 ↗
• InjuryNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REV LTKA W/ POLY EXCHANGE, PATIENT FELL AND WOUND OPENED, TRIED TO GIVE IT TIME BUT THE WOUND WAS DRAINING." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 20793238 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "POLY EXCHANGE THIS MORNING. PATIENT FELL ON HIS BATHROOM TILE AND INCISION DEHISCED." SPOKE TO REP: AS THE PATIENT'S WOUND OPENED DOWN INTO THE JOINT, THE 5X9 MM PS INSERT WAS REVISED PROPHYLACTICALLY. INFECTION WAS NOT SUSPECTED AND NO WORKUP FOR INFECTION WAS PERFORMED. PATIENT WAS REVISED TO A NEW 5X9 MM PS INSERT. LEFT KNEE. ASIDE FROM USAGE SHEETS, CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall

  MAUDE report 11840077 ↗
• InjuryNov 19, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LIGAMENT INSTABILITY. A 5X9 PS INSERT WAS REVISED TO A 5X13 PS INSERT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT, PROVIDED AN EXPLANT PICTURE AND USAGE INFORMATION FOR THE PRIMARY AND REVISION PROCEDURES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 10867623 ↗

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-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 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-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 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