Triathlon 5531-G-419Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327045826), received between May 12, 2017 and Jan 8, 2021 — classified as 3 injuries.

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

• InjuryJan 8, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. THE SURGEON'S ORIGINAL PLAN WAS TO REVISE A 4X19 CS INSERT TO A 4X22 CS INSERT. HOWEVER, THE SURGEON WAS NOT SATISFIED WITH THE STABILITY OF THE JOINT AND REVISED THE PATIENT'S KNEE FROM A CR KNEE TO A TS KNEE. THE PATIENT'S RESURFACED PATELLA WAS NOT REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED DEVICES, PROVIDED THE PRIMARY USAGE SHEET, AND ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Joint Laxity

  MAUDE report 11140818 ↗
• InjuryJul 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT REVISION FOR INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7675511 ↗
• InjuryMay 12, 2017Contamination; Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED A REVISION WAS PERFORMED ON A PATIENT WITH AN INFECTION. PATIENT WENT IN FOR I&D AND TIBIAL INSERT EXCHANGE OF THE RIGHT KNEE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6564688 ↗