Triathlon 5532-G-409-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327338355), received between Apr 2, 2021 and May 28, 2026 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unstable” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF PS POLY, TO CS POLY DURING KNEE INVESTIGATION INFECTION. NOTIFICATION OF REVISION FOR INFECTION ONLY.

  Patient problems: Unspecified Infection

  MAUDE report 25315844 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISION DUE TO INFECTION. FEMUR, TIBIAL INSERT & BASEPLATE WITH STEM REMOVED, WASH OUT, AND NEW IMPLANTS PUT IN.

  Patient problems: Unspecified Infection

  MAUDE report 25305100 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 23001792 ↗
• InjuryJul 21, 2024Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED BY REP: "PATIENT REVISED DUE TO INSTABILITY. FEMUR AND TIBIAL COMPONENTS, PATELLAR COMPONENT, ALL RETAINED. WE SWITCHED OUT THE POLY ONLY." REVISION WAS PERFORMED ROBOTICALLY. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 19788922 ↗
• MalfunctionOct 23, 2023Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

  WHEN THE IUD WAS REMOVED FROM THE PACKAGING DURING IMPLANTATION, IT HAD A LOOSE LOCKING WIRE. THE SURGEON HAD TO TAKE ANOTHER IMPLANT, THIS ONE WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17983375 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO SUSPECTED INFECTION. SURGEON PERFORMED A WASHOUT AND POLY SWAP. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 17140482 ↗
• MalfunctionDec 22, 2022Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  LOCK RING FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16038668 ↗
• InjuryNov 14, 2022Unstable; Unstable

  THE FOLLOWING WAS REPORTED: TOTAL KNEE REVISION FOR INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 15794978 ↗
• InjuryMay 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "PT. SUFFERED A FALL AND FELT HER KNEE WAS UNSTABLE, SUBSEQUENTLY. DR. SWAPPED THE PRIOR 'PS INSERT' FOR A 'TS INSERT'. NO COMPLAINTS HAVE BEEN FILED AGAINST THE IMPLANTS THEMSELVES." SPOKE TO REP. PATIENT TRIPPED AND FELL DIRECTLY ON HER KNEE. REP CONFIRMED THERE ARE NO ALLEGATIONS OF MALPOSITIONED IMPLANTS.

  Patient problems: Fall; Pain

  MAUDE report 14432592 ↗
• InjuryApr 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND INFECTION. A 4X9 PS INSERT WAS EXCHANGED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 14160658 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED "THE SAE HAPPENED ON (B)(6) 2022. THIS PATIENT HAD FUNCTIONAL LOSS DUE TO ARTHROFIBROSIS 8 WEEKS POSTOPERATIVELY. AT (B)(6) 2022 THE PATIENT WAS HOSPITALIZED TO PERFORM MANIPULATION UNDER ANESTHESIA. NO EXPLANT OR REVISION SURGERIES WERE DONE OR PLANNED. THE EVENT IS RELATED TO THE PROCEDURE (TOTAL KNEE ARTHROPLASTY), BUT WE CANNOT SAY YET WHETHER THIS IS ALSO RELATED TO THIS SPECIFIC IMPLANT."

  Patient problems: Ambulation or Postural Difficulties; Fibrosis

  MAUDE report 13859413 ↗
• InjuryMar 1, 2022Unstable; Unstable

  AS REPORTED: "PT PRESENTED WITH COMPLAINT OF INSTABILITY FOLLOWING TKA OF THE RIGHT-KNEE ON (B)(6) 2020. DR. (B)(6) SWAPPED OUT THE [4X9] PS INSERT FOR A THICKER OPTION [4X12 PS], LEAVING ALL OTHER COMPONENTS IN-SITU." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 13640366 ↗
• MalfunctionApr 2, 2021Device Difficult to Setup or Prepare; Device-Device Incompatibility; Device Difficult to Setup or Prepare; Device-Device Incompatibility

  A PS POLY #4 9MM WAS USED BUT FOUND TO HAVE A SUBSTANDARD LOCKING MECHANISM. THE SURGEON DECIDED TO NOT USE IT AFTER FAILING TO SEAT IN ON THE TIBIA AND ANOTHER ONE HAD TO BE ORDERED IN. THE SURGEON COULDN'T GET THE POLY SEATED CORRECTLY ON THE BASEPLATE. A DIFFERENT POLY WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 11607095 ↗

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-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-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-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