Triathlon 5532-G-413-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327338560), received between Jul 22, 2021 and Jan 8, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

6 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.

Recalls naming this device

1. Apr 13, 2023Open, Classified

   Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa

   Z-1654-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionJan 8, 2025Material Deformation; Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information

  HOSPITAL REPORTED "DAMAGED IMPLANT". NO MORE INFORMATION AVAILABLE FOR NOW.

  Patient problems: Insufficient Information

  MAUDE report 21102576 ↗
• InjuryMay 21, 2024Unstable; Unstable

  AS REPORTED: "REVISION RTKA W/ POLY EXCHANGE, GLOBALLY UNSTABLE, WENT TO THICKER POLY." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 19367992 ↗
• MalfunctionMay 10, 2023Device Damaged Prior to Use; Device Dislodged or Dislocated; Device Damaged Prior to Use; Device Dislodged or Dislocated

  IT WAS REPORTED: "THE CUSTOMER INFORMED THAT WHEN AT THE OPENING OF THE IMPLANT, IT WAS NOT IN PERFECT CONDITION TO BE IMPLANTED¿. A PICTURE HAS BEEN PROVIDED AND SHOWS THE LOCKING WIRE IS NOT IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16901543 ↗
• InjuryJul 22, 2021Adverse 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. AS REPORTED BY REP: "WASHOUT / POLY EXCHANGE FOR INFECTION. NO REP PRESENT FOR THE CASE." SPOKE TO THE REP, WHO WAS NOTIFIED OF THE REVISION 1 DAY POST-OP. A 4X13 PS INSERT WAS EXCHANGED FOR ANOTHER 4X13 PS INSERT. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12211537 ↗

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-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-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-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM