Triathlon 5532-G-411-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327338607), received between Nov 4, 2020 and May 1, 2025 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2025Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  NO NEW INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21940910 ↗
• InjuryNov 14, 2024Adverse 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 PATIENT UNHAPPINESS. ALL COMPONENTS WERE FOUND TO BE WELL FIXED AND WELL POSITIONED. A PS KNEE WAS CONVERTED TO A TS KNEE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 20684931 ↗
• InjuryMar 6, 2024Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  PATIENT REPORTED, A POPPING IN HIS LEFT KNEE. PAIN WAS ALSO REPORTED.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 18844603 ↗
• InjuryFeb 20, 2024Adverse 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. AN INSERT EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 18737367 ↗
• InjuryApr 28, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENTS RIGHT KNEE WAS REVISED DUE TO INSTABILITY (OTHER PATIENT COMPLAINTS INCLUDED A TIGHT BANDLIKE FEELING, 'CRUNCHINESS' OR NOISE WHEN STANDING OR SITTING, DISCOMFORT, AND WEAKNESS). A 4X11 PS INSERT WAS REVISED TO A 4X13 TS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity; Pain; Rheumatoid Arthritis

  MAUDE report 16839339 ↗
• InjuryAug 17, 2022Unstable; Unstable

  IT WAS REPORTED THE PATIENT'S RIGHT KNEE WAS REVISED. THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT AND SUFFERED A PELVIC FRACTURE, AND WAS EXPERIENCING INSTABILITY. ONCE THE FRACTURE WAS ADDRESSED, THE SURGEON DECIDED TO REVISE A 4X11 PS INSERT TO A 4X13 TS INSERT.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s)

  MAUDE report 15238422 ↗
• InjuryAug 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO POSSIBLE INFECTION. A 4X11 PS INSERT WAS REVISED TO A 4X13 PS INSERT. SPOKE TO REP: CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12286545 ↗
• InjuryNov 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REP REPORTED THAT: "PT. FELL AND RUPTURED HER INCISION. DR. PERFORMED AN IRRIGATION-AND-DEBRIDEMENT (I&D), AND SWAPPED OUT THE PS INSERT AS PART OF HIS I&D PROTOCOL. SHE WAS WASHED OUT BACK IN (B)(6) DUE TO A WOUND DEHISCENCE INCIDENT ((B)(6) 2020). THE INSERT THAT WAS IMPLANTED IN SEPTEMBER IS THE ONE WE REPLACED TODAY."

  Patient problems: Fall

  MAUDE report 10786949 ↗

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-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-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-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 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-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