Triathlon 5531-G-211-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327336504), received between Feb 28, 2022 and Aug 14, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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 16, 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.

• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: "LEFT TOTAL KNEE. THE REVISION TODAY WAS DUE TO EXCESS SCAR TISSUE FORMATION RESULTING IN LIMITED RANGE OF MOTION. THE JOINT WAS EXPOSED, SCAR TISSUE REMOVED AND THE INSERT WAS REPLACED WITH A THINNER INSERT TO ALLOW GREATER RANGE OF MOTION. THE USE OF MAKO DURING THE INDEX PROCEDURE WAS NOT THOUGHT TO HAVE CONTRIBUTED TO THIS COMPLICATION. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL."

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 22803491 ↗
• InjuryDec 10, 2024Unstable; Unstable

  REVISED THE TIBIAL INSERT OF A RIGHT TRIATHLON TOTAL KNEE DUE TO PATIENT LOOSENESS / HYPEREXTENSION. HE FELT THE PATIENT'S LIGAMENTS STRETCHED OUT. HE REVISED FROM A 2X11 CS TO 2X14 CS.

  Patient problems: Joint Laxity

  MAUDE report 20896175 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. REASON FOR REVISION WAS NOT REPORTED TO THE REP, BUT X-RAYS WERE PROVIDED. A BASEPLATE, INSERT, AND PATELLAR COMPONENT WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 15527009 ↗
• InjuryFeb 28, 2022Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  PATIENT HAD A INDEX RTKA IN (B)(6) 2021. PATIENT HAD A TRAUMA AND DEVELOPED A DISRUPTION OF THE EXTENSOR MECHANISM THAT REQUIRED REVISION ON (B)(6) 2021. ONLY THE POLY COMPONENT WAS EXCHANGED.

  Patient problems: Ambulation or Postural Difficulties; Fall; Insufficient Information; Muscle/Tendon Damage

  MAUDE report 13618862 ↗

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-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1265-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 MM
• Z-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 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