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ADVANCE® KTCCNP21Recalls & reported problems

Microport Orthopedics Inc. · ADVANCE® II CoCr TIBIAL BASE NONPOROUS SZ 2+ · Class 2 · Implant

Adverse event reports
6
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684KTCCNP211), received between Jun 23, 2020 and Jan 30, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information3
  • Loss of Osseointegration2
  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Bone Fracture(s)2
  • No Information2
  • Unspecified Infection2

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

    ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE REVISION NJR NUMBER. SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

    Patient problems: Bone Fracture(s)

    MAUDE report 16263241 ↗
  • InjuryAug 3, 2022Appropriate Device Problem Term/Code Not Available

    ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: 4882220. SIDE: R . PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

    Patient problems: Unspecified Infection

    MAUDE report 15156289 ↗
  • InjuryJun 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: 4348919. SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

    Patient problems: Unspecified Infection

    MAUDE report 10206550 ↗
  • InjuryJun 23, 2020Loss of Osseointegration; Loss of Osseointegration

    ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING TIBIA. COMPONENT NOT REVISED: ADVANCE RECESSED ALL POLY PATELLA HIGH DOME 25MM PRODUCT ID: KPRC25HI LOT #: 128767095, REVISION NJR NUMBER: 2153826, SIDE: L, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

    Patient problems: No Information

    MAUDE report 10183681 ↗
  • InjuryJun 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI PROSTHETIC FRACTURE. COMPONENT NOT REVISED: ADVANCE II MEDIAL PIVOT TIBIA INSERT SZ 2 RIGHT 12MM PRODUCT ID: KIMP212R LOT #: 04480875. ADVANCE RECESSED ALL POLY PATELLA HIGH DOME 25MM PRODUCT ID: KPRC25HI LOT #: 05485149. REVISION NJR NUMBER: 4058499. SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

    Patient problems: Bone Fracture(s)

    MAUDE report 10183525 ↗
  • InjuryJun 23, 2020Loss of Osseointegration; Loss of Osseointegration

    ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING TIBIA. REVISION NJR NUMBER: 4289228, SIDE: R, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

    Patient problems: No Information

    MAUDE report 10183445 ↗

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

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

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.