Triathlon 5531-P-413Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327042252), received between Dec 10, 2021 and May 20, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. A 4X13 INSERT WAS EXCHANGED FOR A 4X14 INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 14461030 ↗
• InjuryJan 20, 2022Unstable; Unstable

  AS REPORTED: PLEASE FIND INFORMATION FROM INDEX AND REVISION SURGERIES ON A RIGHT KNEE. THE SURGEON REPORTED THAT THE PATIENT RECENTLY LOST 100 LBS AND COMPLAINED OF INSTABILITY IN THE KNEE. NO FURTHER INFORMATION AVAILABLE." PATIENT WAS REVISED FROM A 4X13 INSERT TO A 4X19 INSERT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL COMPONENT. THE COMPONENT WAS WELL-FIXED, BUT THE SURGEON WANTED TO CONVERT THE KNEE FROM CR TO PS. REP CONFIRMED THAT ASIDE FROM THE PROVIDED PRIMARY AND REVISION USAGE SHEETS, NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 13311636 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISION TODAY WAS AN I&D FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 12974716 ↗