Triathlon 5531-G-310-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327390544), received between May 19, 2022 and Nov 4, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Unstable” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 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.

Recalls naming this device

1. Feb 6, 2024Class IIOpen, Classified

   Potential packaging breaches of inner blister and outer sterile blister.

   Z-1259-2024 · Root cause: Packaging · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Unstable; Unstable

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A 3X10 CS INSERT WAS REVISED TO A 3X12 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 23469257 ↗
• InjuryApr 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. ALL IMPLANTS OF A CR KNEE WERE REMOVED AND A TS KNEE WITH STEMS AND AUGMENTS WAS IMPLANTED (REP REPORTED THE SURGEON WAS CONCERNED ABOUT BONE LOSS AND WANTED TO ENSURE ADDITIONAL STABILITY. THERE WERE NO ADDITIONAL PATIENT COMPLAINTS THAT LED TO THE CONVERSION). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 21775433 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED "STAGE 1 REVISION, REMOVAL OF STRYKER IMPLANTS AND INSERTION OF CEMENT SPACER PRIOR TO RE IMPLANTATION AND SECOND PROCEDURE. SUSPECTED INFECTION."

  Patient problems: Unspecified Infection

  MAUDE report 20201623 ↗
• InjuryOct 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD PAIN AND SWELLING IN OFFICE NOTE ON (B)(6) 2022. RIGHT KNEE WAS ASPIRATED. MONITORED PROGRESS AND DECIDED TO DO A CLOSED MANIPULATION ON (B)(6) 2022. PATIENT'S NEXT APPOINTMENT IS ON (B)(6) 2022.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 15593012 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "RIGHT KNEE I&D, POLY EXCHANGE. CELLULITIS OF DRAINAGE SITE. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL."

  Patient problems: Unspecified Infection

  MAUDE report 15127071 ↗
• InjuryMay 19, 2022Adverse 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. KNEE EFFUSION DEVELOPED APPROXIMATELY 2 WEEKS AFTER THE PATIENT FELL. AN IRRIGATION AND DEBRIDEMENT WITH POLY EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall; Swelling/ Edema

  MAUDE report 14433714 ↗

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-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