Triathlon 5551-G-320-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327314649), received between Aug 11, 2021 and May 6, 2026 — classified as 4 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 18, 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.

• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISION RIGHT PFJ DUE TO INFECTION. ARTICULATING SPACER WAS IMPLANTED TODAY. NO ADDITIONAL DETAILS TO BE REPORTED BY THE FACILITY.

  Patient problems: Unspecified Infection

  MAUDE report 25092417 ↗
• InjuryNov 12, 2024Loss of Osseointegration; Loss of Osseointegration

  THIS PI IS FOR THE LEFT KNEE. AS REPORTED: "DR. IS ASKING FOR US TO DOCUMENT AN INSTANCE OF ASEPTIC LOOSENING FOR A PATIENT SHE OPERATED ON (B)(6) 2022. THE PATIENT HAD BILATERAL TKA AND IS NOW BEING REVISED ON BOTH SIDES FOR LOOSENING. SHE HAD SHARED THE IMPLANT INFORMATION AND ASKED THAT WE CHECK THE LOT NUMBERS FOR ANY RECALLS." NONE OF THE REPORTED IMPLANTS WERE SUBJECT TO RECALL.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20666256 ↗
• InjuryNov 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A FALL, RUPTURED EXTENSOR MECHANISM AND LOOSENING OF THE TIBIAL COMPONENT. IMPLANTS REMOVED, CEMENT SPACER IMPLANTED. RIGHT TRIATHLON. SALES REPS RESPONSE CONFIRMS THAT ALL DEVICES WERE REMOVED.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 18070546 ↗
• InjuryAug 11, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO ANTERIOR KNEE PAIN. INTRA-OPERATIVELY, THE PATELLAR COMPONENT WAS FOUND TO HAVE A LATERAL FRACTURE AND THE PEGS SHEARED OFF. THE PATELLAR COMPONENT AND LINER WERE REVISED. REP CAN PROVIDE PICTURES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 12306187 ↗

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-1265-2024 · 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-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-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