Triathlon 5551-G-299-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327314656), received between Nov 18, 2022 and Aug 25, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Loss of Osseointegration

  Second revision TKA. Reason for revision: loosening. Outcome: all implants removed, TS femur implanted, universal baseplate implanted, TS insert implanted.

  Patient problems: Inadequate Osseointegration

  MAUDE report 50435584 ↗
• InjuryMar 4, 2026Fracture; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: INITIAL IMPLANTS PLACED IN 2022. REVISION KNEE (B)(6) 2026 - PATELLA BUTTON REMOVED.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 24511466 ↗
• InjuryMay 9, 2024Mechanical Problem; Mechanical Problem

  AS REPORTED: "REVISION LTKA. REVISING POLY TODAY SO DOCTORS CAN REMOVE HO BONE AND TRY TO GET THE PATIENT MORE FLEXION AND A SCAR REVISION. NO HARM TO POLY. 2X13MM TS POLY CAME OUT AND THE A29 PATELLA. 2X9MM TS POLY BACK IN TO HELP PATIENT GET BETTER FLEXION." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 19278840 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: REVISION OF THE PATIENT'S RIGHT KNEE ON THE (B)(6) 2022 DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15824595 ↗

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-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-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 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-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