Triathlon 5531-G-109-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327336740), received between Sep 15, 2022 and Mar 11, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2024Mechanical Problem; Mechanical Problem

  RIGHT KNEE SCAR TISSUE AND PCL RESECTION WITH A TIBIAL INSERT EXCHANGE DUE TO LACK OF RANGE OF MOTION.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 18873960 ↗
• InjuryMar 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO SOFT TISSUE ADHESIONS AND LACK OF ROM. A 1X9 CS INSERT WAS SWAPPED FOR ANOTHER 1X9 CS INSERT.

  Patient problems: Adhesion(s); Loss of Range of Motion

  MAUDE report 16636146 ↗
• InjurySep 15, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "PATIENT REVISED DUE TO SCAR TISSUE AND FLEXION INSTABILITY. IMPLANT NOT AVAILABLE AND NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." A 1X9 CS INSERT WAS REVISED TO A 1X11 CS INSERT.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Scar Tissue

  MAUDE report 15433432 ↗

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-1266-2024 · 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-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• 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-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