Triathlon 5532-G-412-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327390469), received between Apr 23, 2019 and Aug 20, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K173849); 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.

• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I & D AND INSERT-SWAP. PT. PRESENTED WITH A DRAINING SURGICAL WOUND FOLLOWING MAKO-TKA ON (B)(6) 2024. NO SUSPICION OF INFECTION AS OF YET, BUT DR. WAS CONCERNED ABOUT THE WOUND DRAINING "THIS LONG AFTER SURGERY". HE OPTED TO PERFORM AN EXTENSIVE I&D AND SWAP OUT THE INSERT. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 20001133 ↗
• InjuryNov 15, 2023Unstable; Unstable

  THIS PI IF FOR REVISION. PATIENT REPORTED A PRIMARY RIGHT KNEE SURGERY ON (B)(6) 2021 AND HAD A REVISION DUE TO INSTABILITY AND PAIN ON (B)(6) 2022. PATIENT STATED SHE DID NOT HAVE ANY IMPLANTS REMOVED OR REPLACED. PATIENT REPORTED CONTINUED PAIN AND ON (B)(6) 2023, LEG "WENT OUT" AND FEMUR BROKE. PATIENT NOTED SURGEON WANTS TO PERFORM ANOTHER SURGERY TO IMPLANT A ROD TO ADDRESS THE BROKEN FEMUR. PATIENT HAS NOT SCHEDULED ANOTHER REVISION. PATIENT NOTED SHE IS TAKING UP TO 5 OXYCODONE PILLS PER DAY FOR THE PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18139594 ↗
• MalfunctionApr 23, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  PRIMARY PROCEDURE OF THE KNEE. IT WAS REPORTED THAT THE INSERT WOULD NOT LOCK INTO THE BASEPLATE. ANOTHER DEVICE OF THE SAME CATALOG NUMBER (DIFFERENT LOT) WAS USED AND PERFORMED AS EXPECTED. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8541830 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173849. One submission often covers many models, so check the product and lot details in each record.

• Z-1260-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 10 MM
• Z-1259-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 3 10 MM
• Z-1653-2023 · Apr 13, 2023 · Open, Classified
  TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E