Triathlon 5532-G-512-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327391107), received between Oct 23, 2020 and Sep 7, 2021 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "DOING AN I&D W/ POLY SWAP ON THE PATIENT. WOUND DEHISCENCE. RIGHT KNEE" SPOKE TO REP: CONFIRM THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Wound Dehiscence

  MAUDE report 12433922 ↗
• InjuryOct 23, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. SURGEON REPORTED THAT LATERAL INSTABILITY WAS CAUSED BY SOFT TISSUE WEAKENING DUE TO THE PATIENT'S VERY ACTIVE LIFESTYLE. A 5X12 PS INSERT WAS REVISED TO A 5X13 TS INSERT. REP PROVIDED THE PRIMARY USAGE SHEET AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 10725212 ↗

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