Triathlon 5531-P-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327391824), received between Apr 21, 2021 and Aug 1, 2022 — 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 18, 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.

• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: INDEX AND REVISION SURGERY OF A RIGHT TOTAL KNEE REPLACEMENT. REVISION WAS PERFORMED DUE TO COMPLAINT OF PAIN AND SUSPICION OF TIBIAL LOOSENING DUE TO X-RAYS. IT WAS DETERMINED THAT THE TIBIA AND FEMUR WERE WELL FIXED AND A 12 MM INSERT ADDED STABILITY."

  Patient problems: Pain

  MAUDE report 15137422 ↗
• InjuryApr 21, 2021Unstable; Unstable

  AS REPORTED: "REVISION SURGERY OF LEFT KNEE. REVISION FOR INSTABILITY." SPOKE TO REP: REP CONFIRMED NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON AND THAT THERE WERE NO INTRAOPERATIVE FINDINGS THAT COULD BE A CAUSE OR CONTRIBUTOR FOR INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 11704637 ↗

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