Triathlon 5532-G-712-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327392142), received between May 14, 2024 and May 14, 2024 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED RIGHT TOTAL KNEE. REVISION SECONDARY TO INFECTION. THE USE OF MAKO IN THE INDEX PROCEDURE WAS NOT THOUGHT TO HAVE CONTRIBUTED TO THIS COMPLICATION. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL.¿ A PS KNEE WAS CONVERTED TO A KNEE WITH PS/TS KNEE WITH STEM AND AUGMENTS. ADDITIONAL INFORMATION FROM REP (REGARDING CONVERSION OF KNEE FROM PS TO PS/TS): AFTER THE IMPLANTS WERE REMOVED AND CLEAN UP CUTS WERE MADE THERE WAS A LARGE GAP BETWEEN FEMUR AND TIBIA. THROUGH TRIALING IT WAS DETERMINED THAT 10MM AUGMENTS WITH A 22MM INSERT STABILIZED THE JOINT. DR MADE THE DECISION TO USE A CONSTRAINED INSERT TO INSURE STABILITY LONG TERM.

  Patient problems: Unspecified Infection

  MAUDE report 19315887 ↗

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