Triathlon 5537-G-313-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327287974), received between Oct 28, 2021 and Nov 28, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT REVISED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED IN A SPACER WAS IMPLANTED. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20805420 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." RIGHT KNEE. A 3X13 TS INSERT WAS EXCHANGED FOR ANOTHER.

  Patient problems: Unspecified Infection

  MAUDE report 19508541 ↗
• InjuryApr 17, 2024Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT HAD GLOBAL INSTABILITY REQUIRING TOTAL KNEE REVISION. THE PATIENT FELL AND DISLOCATED THEIR KNEE.

  Patient problems: Fall; Joint Dislocation; Joint Laxity

  MAUDE report 19127965 ↗
• InjuryFeb 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I&D WITH TIBIAL INSERT SWAP OF A TS RIGHT KNEE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18702566 ↗
• InjuryJul 20, 2022Fracture; Fracture

  PATIENT REPORTED A PRIMARY RIGHT KNEE REPLACEMENT ON (B)(6) 2022 AND A REVISION ON (B)(6) 2022 DUE TO "LOCKING DEVICE PLATE & BUSHING" BROKE. PATIENT REPORTED THE SURGEON REMOVED A "ROUND PLASTIC DISK" WHICH ALLEGEDLY BROKE IN HALF. PATIENT CLAIMED NO SPECIFIC TRAUMA PRIOR TO REVISION.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 15063702 ↗
• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT TOTAL KNEE. REVISION WAS DUE TO INFECTION. NO FURTHER INFORMATION AVAILABLE FROM THE HOSPITAL OR SURGEON. A 3X13 TS INSERT WAS REVISED TO A 3X16 TS INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 14982639 ↗
• InjuryOct 28, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED BY REP: "PT. PRESENTED WITH SYMPTOMS OF AN ACUTE-INFECTION. PT¿S KNEE WAS WASHED OUT, TISSUE-SAMPLES TAKEN FOR CULTURE, AND X3-INSERT SWAPPED OUT AS PART OF DR¿S I&D PROTOCOL, NO COMPLAINTS HAVE BEEN FILED AGAINST THE IMPLANTS THEMSELVES." SPOKE TO REP, WHO SUPPLIED 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 12712302 ↗

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-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-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-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