Triathlon 5531-G-214-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327391398), received between Jan 7, 2025 and May 27, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Unstable” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Unstable

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF POLY LINER. NEEDED TO PUT IN A THICKER POLY. PATIENT'S KNEE OPENED UP SINCE LAST SURGERY AND BEGAN TO HYPER EXTEND. TOOK OUT A 2 X 14 CS AND IMPLANTED A 2 X 19 CS.

  Patient problems: Joint Laxity

  MAUDE report 25306105 ↗
• InjuryJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I&D INSERT EXCHANGE DUE TO POSSIBLE INFECTION OF A RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21089927 ↗

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-1259-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 3 10 MM
• Z-1260-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 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