Triathlon 5532-G-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327046144), received between Jan 15, 2018 and Oct 6, 2020 — 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.

• MalfunctionOct 6, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  THE WIRE WHICH IS RESPONSIBLE FOR THE LOCKING MECHANISM OF TRIATHLON PS INSERT #1 11MM CAME OUT DURING THE BILATERAL TKR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10633825 ↗
• InjuryJan 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT HAD INDEX SURGERY OUTSIDE CORS SCOPE. PATIENT UNDERWENT MECHANICAL PROBLEM LEFT TOTAL KNEE REVISION (B)(6) 2015. PATIENT UNDERWENT RESECTION OF LEFT TOTAL KNEE ARTHROPLASTY WITH REPLACEMENT OF HIGH DOSE ANTIBIOTIC HYBRID SPACER AND REVISION OF ALL COMPONENTS FOR PJI IN (B)(6) 2019.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9648909 ↗
• MalfunctionJan 15, 2018Difficult to Insert; Mechanical Problem; Difficult to Insert; Mechanical Problem

  IT WAS REPORTED THAT WHEN IMPACTING THE TRIATHLON INSERT SIZE 1 X 11MM ONTO TIBIAL BASE-PLATE, IT OVERHANGS LATERALLY AS THE STEEL RING IN THE INSERT CAN NOT BE LOCKED TO THE BASE-PLATE. ANOTHER INSERT WITH SIMILAR SPECIFICATION WAS USED AND COMPLETELY FITTED ONTO THE BASE-PLATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7190813 ↗