Triathlon 5532-G-414-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327390759), received between Apr 6, 2022 and Nov 20, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K173849); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2025Adverse 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. SURGEON REPORTED THE REVISION CONSTRUCT AS A 'DYNAMIC SPACER.' AN ASSOCIATED REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 23606345 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT KNEE REVISION PERFORMED. PATIENT PRESENTED WITH DEHISCENCE OF HER SURGICAL WOUND FOLLOWING A LEFT KNEE-REVISION ON (B)(6) 2025. DR. OPTED TO PERFORM AN EXTENSIVE I&D AND INSERT-SWAP. ALL OTHER COMPONENTS LEFT IN-SITU. NO COMPLAINTS HAVE BEEN FILED AGAINST THE COMPONENTS THEMSELVES; NO FURTHER INFO AVAILABLE.

  Patient problems: Wound Dehiscence

  MAUDE report 22584103 ↗
• MalfunctionJan 6, 2025Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

  PRIMARY PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT WHEN REMOVING THE INSERT FROM THE INNER BLISTER AT THE BACK TABLE, THE WIRE WAS HALF DETACHED. THE INSERT WAS DISPOSED AND A SECOND INSERT WAS OBTAINED. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF LESS THAN 5 MINUTES (TOURNIQUET WAS USED). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21080603 ↗
• InjuryApr 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S LEFT KNEE WAS REVISED. A 4X14 PS INSERT WAS REVISED TO A 4X13 TS INSERT. AS REPORTED BY REP: "SURGERY WAS A LINER EXCHANGE DUE TO INFECTION. WE REMOVED THE ORIGINAL LINER AND REPLACED IT WITH A NEW ONE." REVISED PRODUCT WAS OBTAINED BY HOSPITAL AND IS UNAVAILABLE FOR RETURN.

  Patient problems: Unspecified Infection

  MAUDE report 14029693 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173849. One submission often covers many models, so check the product and lot details in each record.

• Z-1260-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 10 MM
• Z-1259-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 3 10 MM
• Z-1653-2023 · Apr 13, 2023 · Open, Classified
  TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E