Triathlon 5532-G-614-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327391961), received between Mar 8, 2021 and Apr 16, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS STATUS POST REVISION RTKA COMPLETED TODAY DUE TO RIGHT KNEE INFECTION. NO ADDITIONAL DETAILS PROVIDED BY THE FACILITY.

  Patient problems: Unspecified Infection

  MAUDE report 21852334 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISION LTKA SINGLE STAGE REVISION FOR INFECTION." A TRIATHLON PS KNEE WAS REVISED TO A TS FEMUR AND TRIATHLON REVISION BASEPLATE AND INSERT WITH STEMS AND AUGMENTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 19565425 ↗
• InjuryMar 8, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO DISLOCATION OF THE PATELLA. SURGEON REPORTED THE CAUSE OF DISLOCATION WAS GROWTH OF SCAR TISSUE AND IMPINGEMENT WITH THE RESURFACED PATELLA. SCAR TISSUE WAS REMOVED AND A 6X14 PS INSERT WAS REVISED TO A 6X16 PS INSERT DUE TO SOME LOOSENING OF THE JOINT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11436924 ↗

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