Triathlon 5531-G-219Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327045697), received between Apr 18, 2019 and May 22, 2019 — classified as 3 injuries.

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

• InjuryMay 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILURE, LEFT TOTAL KNEE ARTHROPLASTY".

  Patient problems: Injury

  MAUDE report 8632949 ↗
• InjuryMay 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT RIGHT KNEE REPLACEMENT (B)(6) 2014. PATIENT UNDERWENT A RIGHT REVISION TOTAL KNEE ARTHROPLASTY (B)(6) 2018. AFTER A TWO-STAGE REVISION, PATIENT HAD A FUNCTIONAL ARTICULATING SPACER. REPORTED AS CORS PER 2713 KNEE (PI (B)(4)). NOW THE PATIENT PRESENTS WITH NEW INFECTION AND UNDERGOES A SECOND REVISION IN (B)(6) 2018.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8569797 ↗
• InjuryApr 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGEON REVISED A TRIATHLON INSERT FROM A 2X19 CS TO A 2X16 CS DUE TO STIFFNESS AND PATELLA TENDON TEAR. THIS WAS RELATED TO REVISION SURGERY OF THE PRIMARY KNEE.

  Patient problems: Injury; Loss of Range of Motion; Tissue Damage

  MAUDE report 8527842 ↗