Triathlon 5537-G-409-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327287684), received between Sep 22, 2022 and Dec 16, 2024 — classified as 4 injuries.

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

• InjuryDec 16, 2024Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  SUBJECT IS PART OF THE 76 TRIATHLON CONES REVISION STUDY RECEIVING CONES COMPONENTS ON (B)(6)2021 AND REQUIRED A MANIPULATION UNDER ANESTHESIA ON (B)(6)2022 FOR STIFFNESS/ ARTHROFIBROSIS. LEFT KNEE. NOTE: SUBJECT HAD A NON-STRYKER (LEFT) KNEE IMPLANTED (B)(6) 2021 AND MUA OF THE NON-STRYKER KNEE (B)(6) 2021.

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 20938334 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I&D AND POLY SWAP FOR INFECTION OF A RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17359497 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERFORMED AN I&D WITH TIBIAL INSERT SWAP DUE TO INFECTION. ORIGINAL PROCEDURE WAS (B)(6)2022. IT WAS A REVISION OF AN NON-STRYKER KNEE AT THE TIME.

  Patient problems: Unspecified Infection

  MAUDE report 16285622 ↗
• InjurySep 22, 2022Adverse 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. AS REPORTED: "PT. PRESENTED WITH LIMITED MOBILITY FOLLOWING AN I&D AND INSERT-SWAP ON (B)(6) 2020. DR. PERFORMED A LYSIS OF ADHESIONS/SCAR TISSUE, I&D AND INSERT-SWAP ON (B)(6) 2022 TO HELP THE PT. ACHIEVE GREATER KNEE FLEXION AND IMPROVED MOBILITY OF THE AFFECTED LEG. NO COMPLAINTS FILED AGAINST THE IMPLANTS THEMSELVES."

  Patient problems: Loss of Range of Motion

  MAUDE report 15467140 ↗

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-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 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