Skip to content

ADVANCE® KIDH412RRecalls & reported problems

Microport Orthopedics Inc. · ADVANCE® DOUBLE HIGH TIBIAL INSERT SIZE 4 RIGHT 12MM · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684KIDH412R1), received between Jan 25, 2022 and Jan 25, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1
  • Naturally Worn1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjuryJan 25, 2022Break; Naturally Worn; Break; Naturally Worn

    ALLEGEDLY, ON OR ABOUT (B)(6) 2019, DR. DETERMINED THAT PATIENT'S DEVICE FAILED DUE TO A BROKEN FEMORAL COMPONENT AND WEAR OF THE TIBIAL POLYETHYLENE WHICH WAS FRACTURED THROUGH THE POSTERIOR CONDYLE. PATIENT UNDERGO EMERGENCY SURGERY TO REMOVE THE ADVANCE® KNEE DEVICE.

    Patient problems: Insufficient Information

    MAUDE report 13341818 ↗

Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices

All Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page