Triathlon 5542-A-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327015355), received between Feb 21, 2018 and Nov 27, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2018Fitting Problem; Fitting Problem

  DISTAL BLOCK ON THE RIGHT SIZE 2 (15MM, USED MEDIALLY) DID NOT FIT TO THE CORRESPONDING FEMORAL PROSTHESIS SIZE 2. THERE WAS A CORNER OF THE BLOCKER ON THE ANTERIOR SHIELD OVER OF THE PROSTHESIS. BLOCK OF SIZE 1 WAS USED TO COMPLETE MEDICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8108219 ↗
• MalfunctionMay 8, 2018Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  REVISION OF COMPETITOR DEVICES, RIGHT KNEE. IT WAS REPORTED THE SURGEON COMPLAINED THAT THE AUGMENT WAS OVERHANGING THE FEMORAL COMPONENT ON THE MEDIAL SIDE. THE SURGEON DECIDED TO TRIM THE AUGMENT WITH A DIAMOND WHEEL (B)(4) SO THAT IT DIDN'T OVERHANG THE MEDIAL ANTERIOR FEMORAL FLANGE WITH A SURGICAL DELAY OF APPROXIMATELY 5 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7494385 ↗
• MalfunctionMar 27, 2018Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT IN PERFORMING A REVISION OF PATIENT'S RIGHT KNEE, THE #2 DISTAL FEMORAL AUGMENT WAS OVERHANGING THE MEDIAL SIDE OF THE TRIATHLON #2 FEMORAL COMPONENT AND WOULD NOT ENGAGE THE FEMORAL COMPONENT. A DIFFERENT IMPLANT WAS USED INSTEAD, AND A SURGICAL DELAY OF 8-10 MINUTES WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7373976 ↗
• MalfunctionFeb 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  SIZE 2 15MM DISTAL AUGMENT WAS OVERHANGING ON THE TRIATHLON FEMUR. REP REPORTED THAT AUGMENT IS NOT SUPPOSED TO OVERHANG, AND A SMALLER AUGMENT WAS USED OFF-LABEL. REP CONFIRMED THAT NO SURGICAL DELAY WAS CAUSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7285129 ↗
• MalfunctionFeb 21, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  SIZE 2 15MM DISTAL AUGMENT WAS OVERHANGING ON THE TRIATHLON FEMUR. REP REPORTED THAT AUGMENT IS NOT SUPPOSED TO OVERHANG, AND A SMALLER AUGMENT WAS USED OFF-LABEL. REP CONFIRMED THAT NO SURGICAL DELAY WAS CAUSED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7285126 ↗