Triathlon 5530-G-409-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327382860), received between Aug 13, 2021 and Dec 19, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (1 report).

10 other recalls cover devices cleared under the same FDA submission (K172634, K173849); 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.

• InjuryDec 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORTHOPAEDIC REGISTRAR NOTIFIED STRYKER EMPLOYEE ABOUT PLANNED 1 STAGE REVISION (DAIR) PROCEDURE FOR INFECTION. SURGICAL PLAN, EXCHANGE TIBIAL BEARING. NIL CONCERNS FROM SURGEON RE. IMPLANT, SURGEON UNWILLING TO SHARE ANY FURTHER DETAILS (OP REPORTS, PATHOLOGY, ETC.) DUE TO CONFIDENTIALITY AND NIL CONCERNS OVER IMPLANT PERFORMANCE. PUS WAS FOUND IN THE PATIENT'S KNEE. DEBRIDEMENT AND WASHOUT WAS PERFORMED AND A NEW IMPLANT IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAYS. ADDITIONAL INFORMATION RECEIVED: TIBIAL BASE PLATE REMOVED AND ALL POLY TIBIA IMPLANTED. THIS REVISION WAS DUE TO INFECTION ONLY - NOT IMPLANT FAILURE. COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20979587 ↗
• MalfunctionApr 10, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED BY THE SALES REP THAT THE TRIATHLON X3 TIBIAL BEARING INSERT METAL CLIP THAT SERVE AS A LOCKING MECHANISM WAS SPOTTED DEFECT UPON IMPLANTATION. A REPLACEMENT IMPLANT WAS USED TO COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19083335 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A RELATIVE OF AN ACQUAINTANCE OF A STRYKER EMPLOYEE FROM UK RECENTLY HAD A TKA ON (B)(6) 2021. ATTACHED IN ATTACHMENT-INTAKE IS A PHOTO OF THE IMPLANTS USED. THE SURGERY WAS MAKO ASSISTED. SINCE THE SURGERY SHE HAS HAD ABNORMAL RESULTS, INCONSISTENT WITH A TYPICAL SURGERY. SHE HAS LESS THAN 60 DEGREES OF FLEXION AND THAT IS ONLY WITH MECHANICAL ASSIST. FOR PRIVACY REASONS, I KEEP THE INITIAL REPORTER INFORMATION TO A MINIMUM.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion

  MAUDE report 12317956 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172634, K173849. One submission often covers many models, so check the product and lot details in each record.

• 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-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1259-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 3 10 MM
• Z-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 MM
• Z-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1260-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 10 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
• Z-1653-2023 · Apr 13, 2023 · Open, Classified
  TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E