Triathlon 5537-G-609-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327288162), received between Sep 10, 2020 and Apr 7, 2026 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: HI TEAM, THE PATIENT INVOLVED IN THIS PI HAS HAD FURTHER SURGERY DUE TO INFECTION. I WAS NOTIFIED YESTERDAY AT 5PM THAT THIS PATIENT WOULD BE HAVING ALL IMPLANTS REMOVED TODAY AND A CEMENTED FEMUR AND INSERT INSERTED TO ACT AS A CEMENT SPACER. THE CASE WAS ATTENDED BY MAKO SPECIALIST FROM ANOTHER TERRITORY. I HAVE MANAGED TO GET THE FOLLOWING: ABOUT 2 WEEKS AGO THE PATIENT HAD A WASHOUT OF HIS LEFT KNEE DUE TO INFECTION. YESTERDAY, ALL THE IMPLANTS WERE REMOVED AND THE FOLLOWING IMPLANTED. DUE TO HOSPITAL POLICY, THE IMPLANTS WERE DISPOSED OF. AS THE REVISION WAS DONE BECAUSE OF INFECTION, THE DOCTORS ARE NOT REQUIRING AN INVESTIGATION. HOSPITAL WILL NOT GIVE ME ACCESS TO PATIENT NOTES OR LABORATORY RESULTS. THE INSERT WAS DISPOSED OF ACCORDING TO HOSPITAL POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 24800400 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT KNEE. PT. PRESENTED WITH AN INFECTED KNEE FOLLOWING A PRIOR REVISION. DR. PERFORMED AN EXTENSIVE WASHOUT OF THE SURGICAL SITE AND SWAPPED THE INSERT. ALL OTHER COMPONENTS WERE LEFT IN SITU AT THIS TIME. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, AND NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 23776172 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 23453020 ↗
• MalfunctionJan 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  OPENED TS POLY INSERT AND THE LOCKING WIRE CAME APART FROM THE POLY BEFORE THE SURGEON COULD IMPLANT THE PRODUCT. THIS RESULTED IN ANOTHER IMPLANTED HAVING TO BE SENT FROM THE OFFICE BEFORE THE CASE COULD BE FINISHED. DELAY WAS APPROX 40 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21095556 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. A POLY SWAP WITH I&D WAS PERFORMED. REP PROVIDED THE PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11869257 ↗
• InjurySep 10, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  REP PROVIDED A USAGE SHEET FOR A LEFT KNEE REVISION AND NOTED: "REVISED DUE TO ARTHROFIBROSIS, INSERT EXCHANGE AS PART OF SURGEON I&D PROTOCOL."

  Patient problems: Injury; Scar Tissue

  MAUDE report 10513131 ↗

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-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-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 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