Triathlon 5531-P-309Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327042160), received between Sep 26, 2018 and Dec 16, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE METAL RETAINING PIN ON THE TRIATHLON POLY INSERT BROKE OFF DURING THE INSTALLATION OF THE POLY INSERT - DURING A PRIMARY TOTAL KNEE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20938339 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT HIP DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND COMPETITOR IMPLANTS WERE PLACED AS A TEMPORARY SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 16350824 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PLEASE FIND INFORMATION FROM INDEX AND REVISION SURGERIES OF A LEFT TOTAL KNEE ARTHROPLASTY. REVISION WAS SECONDARY TO PATELLA PAIN AS THE PATELLA WAS NOT RESURFACED DURING INDEX SURGERY. THERE WAS NO MENTION OF THE MAKO HAVING ANY EFFECT ON THE NECESSITY FOR REVISION. NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL OR SURGEON."

  Patient problems: Pain

  MAUDE report 16290497 ↗
• MalfunctionSep 26, 2018Material Deformation; Material Deformation

  THE CUSTOMER REPORTED THAT THE DURING A TOTAL KNEE REPLACEMENT POST INSERTION A METAL WIRE BECAME DETACHED FROM THE POLY INSERT. THE PRODUCT WAS REMOVED FORM THE PATIENT. CASE WAS COMPLETED USING A TRIATHLON CR TIBIAL INSERT #3/9MM USED ¿INSTEAD OF CS INSERT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7912274 ↗