Triathlon 5531-G-613-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327337761), received between Aug 28, 2022 and Jul 30, 2025 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionJul 30, 2025Difficult to Insert; Failure to Advance; Material Deformation; Difficult to Insert; Failure to Advance; Material Deformation

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663106 ↗
• InjuryNov 10, 2022Unstable; Unstable

  AS REPORTED VIA PATIENT LETTER: "...I UNDERWENT TOTAL KNEE REPLACEMENT (TKR) OF MY LEFT KNEE ON (B)(6) 2021. THE DEVICE USED FOR MY TKR WAS THE STRYKER TRIATHLON CEMENTLESS CRUCIATE-RETAINING TOTAL KNEE PROSTHESIS. I HAVE BEEN DIAGNOSED WITH FLEXION INSTABILITY OF GREATER THAN 10MM OF ANTERIOR/ POSTERIOR EXCURSION AS 90 DEGREES FLEXION. BOTH DOCTORS STATED THAT PHYSICAL THERAPY WOULD NOT ALLEVIATE MY FLEXION INSTABILITY, CHRONIC INFLAMMATION, AND PAIN. BOTH DOCTORS STATED THAT REVISION TKR SURGERY WOULD BE NECESSARY. IS STRYKER WORKING ON ANY SORT OF SOLUTION TO FLEXION INSTABILITY ASSOCIATED WITH TKR WITH THE STRYKER TRIATHLON PROSTHESIS SHORT OF REVISION TKR? HOW COMMON IS FLEXION INSTABILITY FOLLOWING TKR WITH THE STRYKER TKR WITH THE STRYKER TRIATHLON PROSTHESIS? WHAT COULD HAVE CAUSED THE FLEXION INSTABILITY? WHAT ACTIONS (DOCTOR TRAINING, BETTER GUIDANCE, ETC) IS STRYKER TAKING TO AVOID FLEXION INSTABILITY IN FUTURE TKR SURGERIES? THE THOUGHT OF HAVING TO ENDURE REVISION TKR IS NOT VERY APPEALING. IF THERE IS SOME SORT OF OTHER SOLUTION TO FLEXION INSTABILITY ASSOCIATED WITH THE STRYKER TRIATHLON PROSTHESIS, PLEASE CONTACT ME."

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Joint Laxity; Pain

  MAUDE report 15767422 ↗
• InjuryAug 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A PRIMARY LEFT TKA ON (B)(6) 2021. THE PATIENT DEVELOPED PAIN IN THE LEFT KNEE AND UNDERWENT REVISION FOR PAIN AND POPLITEUS TENDON RELEASE WITH ONLY THE POLYETHYLENE COMPONENT EXCHANGED ON (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 15307949 ↗

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-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-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-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-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