Triathlon 5550-G-319-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327314779), received between Feb 24, 2021 and Mar 24, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

• InjuryMar 24, 2026Fracture; Noise, Audible

  NO NEW INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24676569 ↗
• InjuryNov 22, 2024Fracture; Fracture

  REVISED KNEE FOR PAIN. THE PATELLA DEVICE PEG HAD BROKEN OFF AND DOCTOR REMOVED AND REPLACED WITH A CEMENTED 31 MM PATELLA. CASE TYPE / APPLICATION: TKA.

  Patient problems: Insufficient Information; Pain; Swelling/ Edema

  MAUDE report 20756275 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE (B)(6) 2020 REVISION. PATIENT UNDERWENT PRIMARY TKA OUTSIDE OF CORS SCOPE. HAD A REVISION TKA ON (B)(6) 2020 FOR PJI. PATIENT HAD A FALL PLUS SUBLUXATION OF THE PATELLA, SHE ALSO HAD SYMPTOMS OF REINFECTION OF THE LEFT KNEE. A REVISION WAS PERFORMED ON (B)(6) 2020, A PERIPROSTHETIC FRACTURE B1 OF THE FEMUR WAS OBSERVED, AND MALTRACKING OF THE PATELLA. ALL COMPONENTS WERE EXCHANGED EXCEPT THE TIBIAL STEM.

  Patient problems: Subluxation; Unspecified Infection

  MAUDE report 11375109 ↗

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-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• 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-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