Triathlon 5516-F-401Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327040814), received between Aug 23, 2018 and Jul 2, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Unstable” (3 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.

• InjuryJul 2, 2025Unstable; Unstable

  AS PART OF AN INVESTIGATOR INITIATED STUDY, A SPREADSHEET WAS PROVIDED INDICATING THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. THE FEMORAL COMPONENT AND INSERT WERE REVISED.

  Patient problems: Joint Laxity

  MAUDE report 22381852 ↗
• InjuryApr 22, 2022Unstable; Unstable

  FOLLOW-UP OF TRIATHLON TRITANIUM OUTCOMES STUDY, PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "PAIN AFTER SITTING FOR LONG PERIOD AND NIGHT PAIN. DISAPPOINTED WITH PAIN AND FEELS LOOSE."

  Patient problems: Joint Laxity; Pain

  MAUDE report 14186941 ↗
• InjuryMay 24, 2021Unstable; Unstable

  TKA WAS REVISED DUE TO PAIN AND INSTABILITY. PATIENT REQUIRED REVISION OF THE FEMORAL COMPONENT. THE FEMORAL COMPONENT WAS EASY TO EXPLANT AND SHOWED NO SIGNS OF INGROWTH DESPITE BEING PRESS FIT. SIGNIFICANT LAXITY WAS OBSERVED IN THE JOINT.

  Patient problems: Pain

  MAUDE report 11872761 ↗
• InjuryMay 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THREE JOINT REPLACEMENTS WERE SCHEDULED ON THE DAY THA>BILATERAL TOTAL KNEE (LEFT KNEE FIRST, THEN RIGHT KNEE). THE INCIDENT HAPPENED DURING THE RIGHT LEG IN THE BILATERAL TOTAL KNEE CASE. DURING THE CASE, 2 TKA CERTIFIED MPS ARE PRESENT AND FOLLOWED THE STANDARD MAKO PROCEDURE. FOR THIS CASE, TRIATHLON CR IMPLANTS WERE INITIALLY PLANNED; DUE TO PATIENT PATHOLOGY, THE SURGEON DECIDED TO CHANGE TO PS CEMENTLESS IMPLANTS. THE CIRCULATING NURSES PROVIDED THE PS IMPLANTS AND HAVE CONFIRMED WITH THE SURGEON. NO STAFFS WERE AWARE THE FEMUR IMPLANT IS THE LEFT SIDE INSTEAD OF THE RIGHT SIDE. THE SURGEON THEN FOLLOWED THE STANDARD PROCEDURE FOR IMPLANTATION, AND MAKO RECORDED THE FINAL LEG TRACKING. THE CASE WAS REVISED ON (B)(6) 2021 BY THE SURGEON. THE WRONG LEFT PS FEMUR IMPLANT WAS CHANGED TO A RIGHT PS CEMENTED FEMUR. DURING THE CASE, FOR BETTER FEMUR ACCESS, THE SAME PS INSERT WAS ALSO EXCHANGED.

  Patient problems: Insufficient Information

  MAUDE report 11818159 ↗
• InjuryAug 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MY HUSBAND HAD A KNEE REPLACEMENT DONE IN (B)(6) 2017 AND FOR SEVERAL MONTHS HAD SWELLING, INSTABILITY AND SEVERE PAIN. THEN HE ENDED UP HAVING A REVISION DONE ON (B)(6) 2018. WHICH THERE IS STILL A LOT OF PAIN AND SWELLING.

  Patient problems: Fibrosis; Injury; Loss of Range of Motion; Pain; Swelling

  MAUDE report 7809134 ↗