Triathlon 5537-G-513-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327287813), received between Mar 10, 2021 and Jul 6, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

6 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.

Recalls naming this device

1. Feb 6, 2024Open, Classified

   Potential packaging breaches of inner blister and outer sterile blister.

   Z-1266-2024 · Root cause: Packaging · Recall details · FDA record ↗

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.

• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: AS REPORTED: "REVISED DUE TO INFECTION." RIGHT KNEE. THE FEMUR AND THE INSERT WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.UPDATE AS PER SALES REP: ALL COMPONENTS WERE REVISED: CONE, STEMS, AUGMENTS, FEMUR, TIBIA, AND INSERT. NOT JUST FEMUR AND INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 25725263 ↗
• InjuryApr 2, 2026Unstable

  THE FOLLOWING INFORMATION WAS PROVIDED: POLY SWAP PERFORMED. CHIEF COMPLAINT WAS INSTABILITY, WHICH WAS FOUND TO BE IN THE SETTING OF SOFT TISSUE INJURY. DR. REPLACED THE LINER AND REPAIRED THE SOFT TISSUE, AND THE REMAINING COMPONENTS WERE LEFT IN SITU. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, AND NO FURTHER INFORMATION AVAILABLE AT THIS TIME. LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24769844 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE REVISION ON (B)(6) 2023. AS REPORTED: "PATIENT IS STATUS POST RIGHT KNEE REVISION DUE TO INFECTION. EXPLANTS ARE INCLUDED ON ORIGINAL USAGE SHEET. ALL WERE REMOVED EXCEPT FOR SIZE 5/13 TS INSERT WHICH WAS REMOVED ON (B)(6) 2022."

  Patient problems: Unspecified Infection

  MAUDE report 18299962 ↗
• InjuryJun 23, 2021Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. THE TS INSERT WAS NOT FULLY SEATED AT IMPLANTATION, WHICH PREVENTED THE METAL POST FROM LOCKING INTO THE BASEPLATE AND SEPARATED FROM THE INSERT. A 5X11 TS INSERT WAS REVISED TO A 5X22 TS INSERT TO ACCOMMODATE FOR THE EXTENSION MECHANISM. REP PROVIDED THE USAGE SHEET FROM THE PRIOR PROCEDURE, EXPLANT PICTURES, AND X-RAYS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 12051974 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO ACUTE INFECTION. A WASHOUT WITH A LINER EXCHANGE WAS PERFORMED. REP PROVIDED A USAGE SHEET FROM A PREVIOUS STAGE 2 REVISION (STAGE 1 REVISION REPORTED) AND MAY BE ABLE TO PROVIDE REVISION USAGE, OTHERWISE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11451736 ↗

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-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-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 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