Triathlon 5532-G-609-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327338096), received between Aug 13, 2020 and Mar 4, 2026 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2026Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: DURING ATTEMPT OF IMPLANTATION OF THE LINER, IT TURNED OUT THAT WIRE IN IT HOLDS ONLY FROM ONE SIDE, AND ITS NOT FULLY EMBEDDED IN THE PRODUCT. PROCEDURE WAS FINISHED WITH SECOND PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511839 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISED A PS TRIATHLON INSERT FROM A 6X9 TO A 6X11 DUE TO PAIN. HE REMOVED SOME SCAR TISSUE AND CALCIFICATION IN THE JOINT SPACE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 22858991 ↗
• InjuryMar 3, 2025Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Arthrofibrosis; Loss of Range of Motion; Pain

  MAUDE report 21503575 ↗
• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REV LTKA W/ POLY EXCHANGE FOR INFECTION." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 21105532 ↗
• InjuryDec 7, 2023Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED EXPERIENCING RIGHT KNEE PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18281568 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS BEEN EXPERIENCING PAIN AND WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL.

  Patient problems: Pain

  MAUDE report 17553506 ↗
• MalfunctionJun 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  FAULT PS SIZE 6/9MM POLY. LOCKING RING FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14800231 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "I&D INSERT EXCHANGE DUE TO INFECTION ON A LEFT TOTAL KNEE." REP PROVIDED A PRIMARY OPERATIVE NOTE AND REVISION USAGE, AND CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE PER HOSPITAL POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 12690144 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. A POLY EXCHANGE WITH I&D WAS DONE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11784591 ↗
• InjuryOct 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. PATIENT FELL ONE DAY POST-OP AND RE-OPENED HIS WOUND. SURGEON PERFORMED A WASH-OUT AND DECIDED TO PROPHYLACTICALLY EXCHANGE THE POLY BEFORE RE-CLOSING THE WOUND. A 6X9 PS POLY WAS SWAPPED FOR ANOTHER 6X9 PS POLY. REP PROVIDED THE PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Fall

  MAUDE report 10739261 ↗
• InjuryAug 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. ALL DEVICES WERE REMOVED AND A SPACER WAS PLACED. REP PROVIDED USAGE SHEETS FROM PRIOR SURGERIES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10401517 ↗

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-1265-2024 · 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-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-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