Triathlon 5537-G-713-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327287806), received between Dec 11, 2020 and Sep 10, 2025 — classified as 3 injuries.

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.

• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Unspecified Infection

  MAUDE report 23022288 ↗
• InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PT. PRESENTED WITH A RUPTURED PATELLAR TENDON OF THE LEFT KNEE. PT. RECEIVED A REVISION OF THE SAME KNEE ON (B)(6) 2022, FROM A PRIMARY TRIATHLON TKA TO A TS REVISION CONSTRUCT . PATIENT ALSO HAD A SUBSEQUENT POLY EXCHANGE (B)(6) 2022. DUE TO THE RUPTURED TENDON, DR. OPTED TO EXPLANT THE PT'S TS CONSTRUCT, IMPLANT AN MRH CONSTRUCT, AND PERFORM A TENDON REPAIR.

  Patient problems: Rupture

  MAUDE report 15394016 ↗
• InjuryDec 11, 2020Adverse 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 AFTER A FALL OPENED THE INCISION. THE WOUND WAS WASHED OUT AND A 7 X 13 TS INSERT WAS REVISED FOR THE SAME TYPE AND SIZE. SPOKE TO REP: REVISION WAS UNDERTAKEN PROPHYLACTICALLY AGAINST INFECTION, NO INFECTION IS ALLEGED. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall

  MAUDE report 10992637 ↗

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-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-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-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