Triathlon 5531-G-811Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327046083), received between Jul 9, 2019 and Mar 2, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2020Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THAT THE PATIENT WAS COMPLAINING OF INSTABILITY. WHEN THE PATIENT WAS BROUGHT TO THE OR AND THE KNEE WAS OPENED IT WAS NOTED THE PS POST WAS BROKEN OFF.

  Patient problems: Failure of Implant; Injury

  MAUDE report 9774415 ↗
• InjuryJul 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DR REPORTS PATIENT A STATUS POST BILATERAL KNEE REPLACEMENT DONE ON (B)(6) 2019 HAS AN INFECTION IN THE RIGHT KNEE AND WOULD LIKE TO DO A WASH OUT AND DEBRIDEMENT AND EXCHANGE THE INSERT. THE SURGERY WAS PERFORMED WITHOUT INCIDENT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8771043 ↗