Triathlon 5537-G-213-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327287967), received between May 8, 2024 and Dec 18, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (2 reports).

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.

• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: RIGHT TOTAL KNEE. REVISION SECONDARY TO A FALL AND PATELLA TENDON RUPTURE. THE INSERT WAS REVISED TO A 19MM TO REGAIN STABILITY LOST DUE TO THE INJURY. THE USE OF MAKO DURING THE INDEX PROCEDURE WAS NOT THOUGHT TO HAVE CONTRIBUTED TO THIS COMPLICATION.

  Patient problems: Fall; Rupture

  MAUDE report 23837029 ↗
• InjuryJun 30, 2025Mechanical Problem; Mechanical Problem

  AS REPORTED: "POLY THICKNESS DOWNSIZED DUE TO LIMITED RANGE OF MOTION. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." A 2X13 TS INSERT WAS REVISED TO A 2X9 TS INSERT.

  Patient problems: Loss of Range of Motion

  MAUDE report 22356847 ↗
• InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REV LTKA- SINGLE STAGE REVISION FOR INFECTION." REP CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 21676340 ↗
• MalfunctionNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT WHEN THE SURGEON PRESSED THE INSERT INTO THE BASEPLATE, THE LOCKING WIRE APPEARED RAISED. AFTER IMPACTION, THE LOCKING WIRE STILL APPEARED RAISED. ON REMOVAL, IT WAS CONFIRMED THE LOCKING WIRE SEPARATED FROM THE INSERT. INSERT WAS WASTED AND A SECOND IMPLANT WAS OBTAINED. THE SECOND IMPLANT LOCKED INTO THE SAME IN-SITU BASEPLATE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 1 MINUTE. WASTED IMPLANT WAS DISPOSED BEFORE THE REP COULD OBTAIN PICTURES. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20756199 ↗
• InjuryMay 8, 2024Mechanical Problem; Mechanical Problem

  AS REPORTED: "REVISION LTKA. REVISING POLY TODAY SO DOCTORS CAN REMOVE HO BONE AND TRY TO GET THE PATIENT MORE FLEXION AND A SCAR REVISION. NO HARM TO POLY. 2X13MM TS POLY CAME OUT AND THE A29 PATELLA. 2X9MM TS POLY BACK IN TO HELP PATIENT GET BETTER FLEXION." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 19268490 ↗

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