Triathlon 5531-G-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327045598), received between Aug 22, 2019 and Aug 23, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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.

• InjuryAug 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO DISLOCATION AND TORN COLLATERAL LIGAMENTS. THE PATIENT'S KNEE CONSTRUCT WAS REVISED TO A HINGED KNEE CONSTRUCT.

  Patient problems: Damage to Ligament(s); Joint Dislocation

  MAUDE report 15273088 ↗
• MalfunctionNov 12, 2019Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT'S WAS REPORTED BY SENIOR SALE SPECIALIST THAT DURING KNEE SURGERY ,SURGEON TRY TO PUSH TIBIA INSERT INTO TIBIA TRAY BUT TIBIA INSERT COULDN'T LOCKED WITH TIBIA TRAY SO THAT SURGEON DECIDED TO CHANGE TO THE NEW ONE. THE OPERATION WAS COMPLETED SUCCESSFULLY AND NO SURGICAL DELAYED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9312056 ↗
• MalfunctionAug 22, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED BY THE SALE REP THAT SMALL GAP WAS FOUND IN BETWEEN TIBIA TRAY AND TIBIA INSERT AFTER THE INSERT WAS LOG IN TO THE TIBIA TRAY NEW TIBIA INSERT WAS USED TO COMPLETED THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8920707 ↗