Triathlon 5530-G-112-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327391411), received between Mar 3, 2022 and Mar 3, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (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 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.

• InjuryMar 3, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S MAKO LEFT KNEE WAS REVISED DUE TO LIMITED RANGE OF MOTION (20° FLEXION, 80° EXTENSION). A SIZE 1 CR FEMUR AND 1X12 CR INSERT WERE REVISED TO A SIZE 1 PS FEMUR AND 1X10 PS INSERT. SURGEON DID NOT REPORT THAT ACCURACY OF BONE CUTS CAUSED OR CONTRIBUTED TO THE ISSUE. REP PROVIDED THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Muscular Rigidity

  MAUDE report 13658194 ↗

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