Triathlon 5531-G-512-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327390803), received between Mar 4, 2020 and Sep 10, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 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.

• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS S/P RIGHT KNEE POLY EXCHANGE OF A 5X12 CS INSERT DUE TO INFECTION. NO ADDITIONAL DETAILS PROVIDED BY THE FACILITY.

  Patient problems: Unspecified Infection

  MAUDE report 23022434 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 22680394 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXPLANTED A RIGHT TRIATHLON KNEE ORIGINALLY IMPLANTED AS PART OF A 2 STAGE REVISION. HE IMPLANTED A CEMENT SPACER AFTER REMOVING THE PARTS DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13150917 ↗
• InjuryMar 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. REVISED A TRIATHLON TIBIAL INSERT PERFORMING AN I&D DUE TO INFECTION OF RIGHT KNEE. ORIGINAL SURGERY WAS (B)(6) 2020.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9786232 ↗

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