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ADVANCE® KTONP40RRecalls & reported problems

Microport Orthopedics Inc. · ADVANCE® OFFSET TIBIAL BASE NONPOR SZ 4 RIGHT MED/LEFT LAT · 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 M684KTONP40R1), received between Jun 29, 2020 and Jun 29, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryJun 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. COMPONENTS NOT REVISED: ADVANCE REVISION FEMORAL SIZE 4 RIGHT NONPOROUS PRODUCT ID: KFCCNP4R LOT ID: 38574513. ADVANCE ONLAY ALL POLY PATELLA 32MM SINGLE PEG PRODUCT ID: KPON32ST LOT ID:45217834. REVISION NJR NUMBER: 1791492. SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

    Patient problems: Unspecified Infection

    MAUDE report 10206376 ↗

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

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Sources and updates

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