Triathlon 5537-G-522-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327287936), received between Sep 28, 2021 and Dec 13, 2022 — classified as 2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR REVISION ON 09/FEBRUARY/2022. PATIENT HAD LEFT INDEX TKA (OUTSIDE OF CORS SCOPE). PATIENT HAS HAD MULTIPLE REVISIONS (OUTSIDE OF CORS SCOPE) FOR INSTABILITY. IN (B)(6), 2021 THE PATIENT IS ADMITTED FOR REVISION DUE TO INSTABILITY. UNDERGOES REVISION OF ALL COMPONENTS. IN (B)(6), 2021 THE PATIENT PRESENTS WITH PJI AND IS REVISED WITH EXCHANGE OF POLY ONLY AND WITH ANTIBIOTIC LOADED CEMENT FOR TREATMENT. ON (B)(6), 2021, THE PATIENT UNDERGOES SECOND REVISION FOR PJI WITH POLY EXCHANGE ONLY. PATIENT PRESENTS WITH INFECTION SYMPTOMS AGAIN AND HAS ANOTHER REVISION ON (B)(6),2022 WITH ALL COMPONENTS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 15967197 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A STAGE 1 REVISION COMPETITOR DEVICES IN THEIR LEFT KNEE ON (B)(6) 2021. THE IMPLANTS USED INCLUDED TRIATHLON STEMS IN THE TIBIA AND FEMUR. A STRYKER REP WHO IS NO LONGER WITH THE COMPANY WAS PRESENT FOR THE PROCEDURE. THE SECOND STAGE REVISION TOOK PLACE ON (B)(6) 2021. DURING THAT REVISION, IT WAS DISCOVERED THAT A 12X50 STEM TRIAL WAS FOUND IN THE PATIENT'S TIBIAL CANAL. UPDATE PER SALES REP: PATIENT HAD STRYKER PARTS IMPLANTED ON (B)(6) 2021 (AFTER REMOVAL OF COMPETITOR PARTS). PATIENT THEN HAD A 2 STAGE REVISION DUE TO INFECTION, WHERE A SPACER WAS IMPLANTED APPROXIMATELY (B)(6) 2021. THE 2ND STAGE OCCURRED ON (B)(6) 2021, WHERE THE SPACER WAS REMOVED AND COMPETITOR PARTS WERE IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 12539834 ↗

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-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-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