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ADVANCE® KIMP414LRecalls & reported problems

Microport Orthopedics Inc. · ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 4 LEFT 14mm · 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 M684KIMP414L1), received between Jun 24, 2020 and Jul 22, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Malposition of Device1
  • Unstable1

Patient problems

  • Loss of Range of Motion1
  • Pain1

Recent adverse event reports

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

  • InjuryJul 22, 2020Appropriate Device Problem Term/Code Not Available

    ALLEGEDLY, PATIENT WAS REVISED DUE TO TIGHTNESS IN FLEXION. THE 14MM INSERT WAS EXPLANTED AND A 12MM INSERT WAS IMPLANTED. (B)(6).

    Patient problems: Loss of Range of Motion

    MAUDE report 10311760 ↗
  • InjuryJun 24, 2020Unstable; Malposition of Device; Unstable; Malposition of Device

    ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING TIBIA, INSTABILITY , MALALIGNMENT AND PAIN. REVISION NJR NUMBER: 4394823. SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

    Patient problems: Pain

    MAUDE report 10192195 ↗

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

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