Triathlon 5531-G-813Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327046434), received between Mar 7, 2024 and Mar 7, 2024 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2024Unstable; Unstable

  CUSTOMER REPORTED: "FROM THE VERY FIRST POST-OPERATIVE PERIOD, THE PATIENT HAS ALWAYS COMPLAINED OF PAIN AND JOINT INSTABILITY IN THE OPERATED RIGHT KNEE. AFTER EVALUATION AT OUR CLINICS WHICH CONFIRMED THE JOINT INSTABILITY, ON (B)(6) 2023 THE PATIENT UNDERWENT TOTAL PROSTHETIC REIMPLANTATION. THE REMOVED PROSTHETIC COMPONENTS APPEARED NEAT, WITH NO MARKS OR OTHER MECHANICAL COMPLICATION. THIS REPORT IS SENT WITH DELAY COMPARED TO THE USUAL TIMES DUE TO COMPUTER ERROR/(PRE-FILLED REPORT, BUT SUBSEQUENTLY MISSING SENDING TO THE COMPETENT OFFICES). PLANTING DATE (B)(6) 2022 (DAY NOT KNOWN).THE REPORT CONCERNS THE ENTIRE IMPLANTATION OF KNEE PROSTHESES."

  Patient problems: Joint Laxity; Pain

  MAUDE report 18859300 ↗