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ADVANCE® SPKT0024Recalls & reported problems

Microport Orthopedics Inc. · ADVANCE® MODULAR KEEL SZ 5-6 · Class 2 · Implant

All models of ADVANCE (147)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684SPKT00241), received between Dec 24, 2019 and Jan 16, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 reports).

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

Device problems

  • Loss of Osseointegration2

Patient problems

  • No Information1
  • Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 16, 2020Loss of Osseointegration; Loss of Osseointegration

    ALLEGEDLY, XRAYS INDICATED THAT IMPLANTS WERE LOOSE. RIGHT KNEE.

    Patient problems: No Information

    MAUDE report 9596861 ↗
  • InjuryDec 24, 2019Loss of Osseointegration; Loss of Osseointegration

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAIN AND XRAYS THAT SHOWED LOOSENING OF IMPLANTS. LEFT KNEE.

    Patient problems: Pain

    MAUDE report 9516703 ↗

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

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Sources and updates

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