ADVANCE® KTCCNP20Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI M684KTCCNP201), received between Jun 25, 2019 and Mar 21, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (6 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

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2024Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING TIBIA. SRNJR NUMBER: (B)(6), SIDE: R, GENDER: F.

  Patient problems: Insufficient Information

  MAUDE report 18955517 ↗
• InjuryJan 23, 2024Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT UNDERWENT LEFT TKA ON (B)(6) 2018 AND WAS IMPLANTED WITH ADVANCE POST STAB FEMORAL. PATIENT WAS REVISED ON (B)(6) 2023 DUE TO ASEPTIC LOOSENING. FEMORAL COMPONENT, TIBIAL COMPONENT, TIBIAL LINER ALL REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 18565271 ↗
• InjuryApr 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE. REVISION NJR NUMBER: 5050346. SIDE: L . PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. PRODUCT NO REVISED: PRODUCT ID: KPONTP32, ADVANCE ONLAY ALL POLY PATELLA 32MM TRIPEG, LOT: 177967, QTY: 1.

  Patient problems: Bone Fracture(s)

  MAUDE report 16726462 ↗
• InjuryApr 12, 2023Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING TIBIA. REVISION NJR NUMBER: 5069778. SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Insufficient Information

  MAUDE report 16725348 ↗
• InjuryJan 31, 2022Fracture

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE. NO REVISED: PART ID KPONTP35, ADVANCE ONLAY ALL POLY PATELLA 35MM TRIPEG, LOT 29792865, QTY 1. REVISION NJR NUMBER: (B)(6). SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Bone Fracture(s)

  MAUDE report 13400866 ↗
• InjuryMay 10, 2021Break; Break

  ALLEGEDLY, PATIENT WAS REVISED DUE TO IMPLANT FRACTURE. REVISION NJR NUMBER: (B)(4). SIDE: L. PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE. MHRA REFERENCE NO: (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11803416 ↗
• InjuryMar 3, 2021Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: (B)(4). SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. MHRA REFERENCE NO: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 11404533 ↗
• InjuryFeb 9, 2021Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING TIBIA. REVISION NJR NUMBER: (B)(4). SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 11304726 ↗
• InjuryDec 7, 2020Loss of Osseointegration; Detachment of Device or Device Component; Loss of Osseointegration; Detachment of Device or Device Component

  ALLEGEDLY, TIBIAL INSERT WAS FOUND TO BE LOOSE FROM THE TIBIAL BASE. PATIENT HAD HER FIRST REVISION ON (B)(6) 2020, IT WAS CAPTURED UNDER INCIDENT NUMBER: (B)(4).

  Patient problems: No Information

  MAUDE report 10961831 ↗
• InjuryOct 9, 2020Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING FEMUR , ASEPTIC LOOSENING TIBIA , LYSIS FEMUR AND LYSIS TIBIA. REVISION NJR NUMBER: (B)(4), SIDE:L, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: No Information

  MAUDE report 10658598 ↗
• InjuryJun 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: (B)(4), SIDE: L, PRIMARY ASA: P3- INCAPACITATING SYSTEMIC DISEASE.

  Patient problems: Unspecified Infection

  MAUDE report 8732930 ↗