Triathlon 5532-G-611-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327338126), received between Sep 11, 2023 and Feb 3, 2026 — classified as 5 injuries.

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

7 other recalls cover devices cleared under the same FDA submission (K172634); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF TRIATHLON TO MRH DUE TO MCL INSUFFICIENCY. NOTIFICATION OF REVISION ONLY.

  Patient problems: Insufficient Information

  MAUDE report 24246177 ↗
• InjuryAug 26, 2025Degraded; Unstable; Degraded; Unstable

  THE PATIENT EXPERIENCED INSTABILITY IN THE KNEE, AND DR. ASSUMED THAT THE POLY HAD BEEN WORN SINCE IT WAS OPERATED ON 10+ YEARS AGO, SO HE DECIDED TO REVISE THE THICKNESS OF THE POLY.

  Patient problems: Joint Laxity

  MAUDE report 22892464 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLY SWAP FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21321625 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMAIL FROM SURGEON: BILATERAL TKR 2021 UNEXPECTED SWELLING : PATIENT HAS ASKED IF ANY LINER FAILURES WITH HIS BATCH OF IMPLANTS. THIS PI CAPTURES THE LEFT SIDE. NO REVISION SURGERIES PLANNED.

  Patient problems: Swelling/ Edema

  MAUDE report 20129857 ↗
• InjurySep 11, 2023Adverse 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. A 6X11 PS INSERT WAS REVISED TO ANOTHER 6X11 PS INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 17717326 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172634. One submission often covers many models, so check the product and lot details in each record.

• Z-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1265-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 MM
• Z-1654-2023 · Apr 13, 2023 · Open, Classified
  TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E