Triathlon 5532-G-511-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327337624), received between Dec 1, 2022 and Sep 18, 2025 — classified as 2 injuries, 1 malfunction.

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

• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PROCEDURE: REVISION LEFT TOTAL KNEE ARTHROPLASTY. INDICATION: DEHISCED INCISION. 5X11 PS X3 TIBIAL INSERT. NOTES: NO CONCERN OF IMPLANT FAILURE, I&D OF DEHISCED INCISION SITE. THAT IS ALL THE INFORMATION THAT THE HOSPITAL WILL RELEASE."

  Patient problems: Wound Dehiscence

  MAUDE report 23088755 ↗
• MalfunctionJul 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING TRIATHLON PS TKR SURGERY, TRIATHLON X3 TIBIAL BEARING INSERT- PS INSERT WAS TO BE IMPLANTED. THE STAINLESS STEEL WIRE PLACED ON THE ANTERIOR/ FRONT SIDE OF THE TRIATHLON X3 PS INSERT CAME OUT WHILE IMPLANTING AND THE INSERT WAS NO LONGER USABLE. THERE WAS ANOTHER TRIATHLON PS INSERT FOR BACK UP SO THAT WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17422280 ↗
• InjuryDec 1, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. REP CONFIRMED THAT NOTHING WAS OBSERVED TO BE WORN, LOOSE, OR BROKEN INTRA-OPERATIVELY. A 5X11 PS INSERT WAS REVISED TO A 5X19 PS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 15896892 ↗

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-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-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-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