Triathlon 5530-G-412-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327391336), received between Jan 27, 2021 and Jan 27, 2021 — 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.

• InjuryJan 27, 2021Adverse 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. DURING PHYSICAL THERAPY 1 DAY POST-OP, PATIENT WAS DIRECTED TO BEND FORWARD AND POPPED HER PATELLAR TENDON. THE TENDON WAS REPAIRED AND A 4X12 CR INSERT WAS REVISED TO A 4X16 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE REVISED BY THE HOSPITAL OR SURGEON.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 11235019 ↗

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