Triathlon 5531-G-210-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327391589), received between Jun 25, 2021 and Jun 24, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Noise, Audible” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT REVISED DUE TO POSSIBLE INFECTION. NO OTHER INFORMATION DUE TO HOSPITAL POLICY. LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25610702 ↗
• InjuryMay 20, 2024Noise, Audible; Noise, Audible

  PATIENT REPORTED THEY HAD A LEFT KNEE MAKO ROBOTIC ASSISTED PROCEDURE AND NOTED HAVING FULL FLEXION AND EXTENSION, BUT REPORTED EXPERIENCING PAIN, SWELLING, HEAT, AND CLICKING.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19356183 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. REVISED A RIGHT TOTAL KNEE DUE TO ARTHROFIBROSIS AND LIMITED RANGE OF MOTION. NO ALLEGATIONS AGAINST THE IMPLANTS MADE. HE REVISED TO A COMPETITOR KNEE.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 17206055 ↗
• InjuryJun 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR... REVISED FROM RIGHT KNEE 2X10 CS INSERT TO A 2X9 INSERT DUE TO STIFFNESS. HE REMOVED SCAR TISSUE AND DID A PARTIAL PCL RELEASE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12065228 ↗

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