Triathlon 5537-G-619Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327027426), received between Feb 16, 2018 and Jan 29, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

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 18, 2026.

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.

• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR REVISION OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2024. AS REPORTED: "PATIENT UNDERWENT TWO POLY EXCHANGES. ONE WAS LAST MONDAY ONE WAS TODAY. POLY EXCHANGES WERE DUE TO INFECTION. X-RAYS ATTACHED. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY."

  Patient problems: Unspecified Infection

  MAUDE report 18594303 ↗
• InjuryNov 13, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. INTRA-OPERATIVELY, THE POLYETHYLENE COVERING THE POST OF THE INSERT WAS SHEARED, WORN, OR FRACTURED OFF THE METAL POST OF THE INSERT. SOME WEAR WAS NOTED WHERE THE INSERT'S METAL POST ARTICULATED AGAINST THE FEMORAL COMPONENT. THE PATIENT'S ENTIRE KNEE CONSTRUCT (SIZE 6 TS FEMUR WITH 2 AUGMENTS AND STEM, 6X19 TS INSERT, SIZE 6 UNIVERSAL BASEPLATE WITH STEM) WAS REVISED TO A TS KNEE. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Pain

  MAUDE report 9314676 ↗
• InjuryJun 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "RIGHT KNEE REVISION DUE TO SEPTIC KNEE". REP PROVIDED PRE-REVISION X-RAYS AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8731666 ↗
• MalfunctionFeb 16, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  SURGEON REPORTED THAT THE TRIATHLON TS 19 MM INSERT WOULDN¿T SIT CORRECTLY IN UNIVERSAL BASE PLATE. HE FURTHER REPORTED THAT HE THEN INSERTED THE TS 16 MM INSERT INTO THE UNIVERSAL BASE TIBIAL BASE PLATE, AGAIN THIS DIDN¿T SEAT PROPERLY, HE IMPACTED THE LINER AGAIN AND INSERTED THE POST AND SAID THAT HE WOULD BRING PATIENT BACK TO THEATRE NEXT DAY FOR A LINER EXCHANGE. THERE WAS A 10 MINUTE DELAY TO SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7277902 ↗