Triathlon 5537-G-611-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327287899), received between May 4, 2021 and Sep 22, 2025 — classified as 2 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 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.

• MalfunctionSep 22, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS PROVIDED: ON (B)(6) 2025, DURING A SURGICAL OPERATION, IT WAS NOT POSSIBLE TO INSTALL AN INSERT DURING A REVISION SURGERY WITH A TRIATHLON TS ENDOPROSTHESIS. THE REASON WAS THAT THE INSERT WAS IN A FAULTY CONDITION, WITH A METAL RIM PROTRUDING FROM THE SLOTS.

  Patient problems: Joint Dislocation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23106922 ↗
• InjuryJan 4, 2023Unstable; Unstable

  AS REPORTED: "PT. PRESENTED WITH INSTABILITY OF THE LEFT KNEE. DR. OPTED TO PERFORM A REVISION OF THE TS+ INSERT AND RESURFACED THE PATELLAR COMPONENT. NO COMPLAINTS FILED AGAINST THE IMPLANTS THEMSELVES".

  Patient problems: Joint Laxity

  MAUDE report 16094110 ↗
• InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PT. PRESENTED WITH A DRAINING SURGICAL WOUND, PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2021. SURGEON OBSERVED THE DRAINAGE WAS FROM THE [LEFT] KNEE JOINT. SURGEON SWAPPED OUT THE TS-INSERT AS PART OF HIS I&D PROTOCOL. NO COMPLAINTS FILED AGAINST THE IMPLANTS, EXPLANTED ITEMS ARE NOT AVAILABLE FOR RETURN DUE TO HOSPITAL POLICY." SPOKE TO REP: NO ALLEGATIONS OF INFECTION. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 11771164 ↗

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-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 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-1265-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 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-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