Triathlon 5531-P-409Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327042238), received between Nov 7, 2018 and Jun 4, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Unstable” (4 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.

• InjuryJun 4, 2025Unstable; Unstable

  THE FOLLOWING WAS REPORTED "LEFT TOTAL KNEE. THE REVISION TODAY WAS DUE TO GENERAL PAIN AND DISCOMFORT. IT WAS DISCOVERED UNDER ANESTHESIA THAT THE KNEE HAD SLIGHT LAXITY. IT WAS DECIDED TO REMOVE THE 9MM INSERT AND REPLACE IT WITH AN 11MM INSERT. THIS PROVIDED SUFFICIENT STABILITY. THE USE OF MAKO DURING THE INDEX PROCEDURE WAS NOT THOUGHT TO HAVE CONTRIBUTED TO THIS COMPLICATION. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL."

  Patient problems: Joint Laxity

  MAUDE report 22144236 ↗
• InjuryJun 13, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  PATIENT SEEING DR. FOR LEFT KNEE INCREASING PAIN, INSTABILITY AND STIFFNESS. REVISION SURGERY OCCURRED ON (B)(6) 2018 WHICH INCLUDED QUADRICEP RELEASE/QUADRICEPSPLASTY.

  Patient problems: Fibrosis; Joint Laxity; Loss of Range of Motion; Muscle/Tendon Damage; Pain; Scar Tissue

  MAUDE report 19526495 ↗
• InjuryMar 27, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "REVISION TODAY WAS DUE TO INSTABILITY IN EXTENSION. THE USE OF MAKO IN THE INDEX CASE WAS NOT MENTIONED AS A CONTRIBUTOR TO THE INSTABILITY. NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL OR SURGEON." A SIZE 4 LEFT CR FEMUR AND 4X9 CS INSERT WERE REVISED TO A SIZE 4 LEFT TS FEMUR WITH STEM AND AUGMENTS, A 4X11 TS INSERT, AND THE PATIENT'S NATIVE PATELLA WAS RESURFACED.

  Patient problems: Joint Laxity

  MAUDE report 16617050 ↗
• InjuryNov 29, 2021Unstable; Unstable

  AS REPORTED: "REVISION SURGERY DONE ON A RIGHT TOTAL KNEE. THE REVISION WAS DONE FOR INSTABILITY. NO OTHER INFORMATION IS AVAILABLE." A CR FEMORAL COMPONENT AND CS INSERT WERE EXPLANTED AND REPLACED WITH A PS FEMORAL COMPONENT WITH TS INSERT, FEMORAL AUGMENT, AND FEMORAL FIXATION PEG. SPOKE TO REP: REP CONFIRMED THAT THERE ARE NO ALLEGATIONS OF ISSUES ARISING FROM BONE CUTS MADE IN THE PRIMARY MAKO PROCEDURE. REP ALSO CONFIRMED THERE WERE NO ADDITIONAL INTRA-OPERATIVE OBSERVATIONS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 12888036 ↗
• InjuryNov 7, 2018Naturally Worn; Naturally Worn

  INSTABILITY, POSTERIOR SAGGING AND WEAR OF PROSTHESIS APPROX. 5 YEARS AFTER IMPLANTATION.

  Patient problems: Injury

  MAUDE report 8046055 ↗