Triathlon 5531-G-711-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327337075), received between Oct 27, 2021 and Dec 11, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 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.

• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. SURGEON EXCHANGED THE INSERT AND THE PATELLAR COMPONENT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 23783551 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR REVISION OF THE PATIENT'S LEFT KNEE ON (B)(6) 2022. SALES REP PROVIDED A USAGE SHOWING THAT THE PATIENT HAD A PREVIOUS REVISION ON (B)(6) 2022. A 7X11 CS INSERT WAS EXCHANGED FOR ANOTHER 7X11 CS INSERT. REPORTING REP WAS NOT PRESENT FOR THE PROCEDURE. REASON FOR REVISION WAS POSSIBLE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16831685 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REMOVAL OF TRIATHLON CR LEFT FEMUR SIZE 7, TRITANIUM BASEPLATE SIZE 7, INSERT 7 CS 11MM DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13150841 ↗
• MalfunctionOct 27, 2021Difficult to Insert; Off-Label Use; Difficult to Insert; Off-Label Use

  MAKO TKA. AFTER ALL KNEE IMPLANTS HAD BEEN INSERTED, INCLUDING A CS POLYETHYLENE INSERT, THEY BEGAN TO START CLOSING UP. AS THEY WERE CLOSING UP, THE SURGEON MADE A COMMENT THAT HE THOUGHT THE POLY LOOKED AS IF IT WAS STICKING OUT A BIT ANTERIORLY BUT THAT HE THOUGHT IT WAS FULLY SEATED. HE THEN USED A PRECISION SAW AND BEGAN TO SAW OFF A PORTION OF THE ANTERIOR POLYETHYLENE INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708626 ↗

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-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 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-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-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