Triathlon 5530-G-310-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327390810), received between Feb 15, 2023 and Feb 15, 2023 — 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 18, 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.

• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT STATES THAT WITHIN A MONTH OF SURGERY, HER LEFT KNEE WAS RED, HOT AND INFECTED. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO RECALL. STATES THAT SHE HAS CONSTANT POPPING AND IS IN PAIN WHEN HER LEG REMAINS BENT. RECENTLY SAW HER DOCTOR WHO INITIALLY THOUGHT SHE WAS SUFFERING FROM PSEUDO GOUT HOWEVER HER C-REACTIVE PROTEIN CAME BACK "HIGH". PATIENT STATES SHE IS CONCERNED THAT SHE IS POSSIBLY ALLERGIC TO THE PRODUCTS IMPLANTED AS SHE HAS HAD SO "MUCH TROUBLE WITH IT FROM THE BEGINNING".

  Patient problems: Unspecified Infection

  MAUDE report 16383675 ↗

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