INSTRUMENT 5530-T-609YRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327402803), received between Oct 4, 2019 and Jan 13, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Fracture; Material Fragmentation

  THE FOLLOWING INFORMATION WAS PROVIDED: ¿BROKEN FRAGMENT ON TRIAL INLAY 6 × 9 MM TRIATHLON.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24052158 ↗
• MalfunctionDec 17, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827357 ↗
• MalfunctionOct 4, 2019Break; Fracture; Break; Fracture

  PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT DURING TRAILING, THE POSTERIOR ASPECT OF THE 6X9 CR TRIAL BROKE IN THE PATIENT. ALL PIECES WERE REMOVED, PATIENT WAS VISUALLY INSPECTED, AND DEVICE WAS REASSEMBLED AT THE BACK TABLE TO ENSURE NOTHING REMAINED IN THE PATIENT. CASE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 1 MINUTE. THE DEVICE IS AVAILABLE FOR RETURN. OTHERWISE, THE REP CONFIRMED THAT NO FURTHER INFORMATION WILL AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9155859 ↗

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