ADVANCE® KTCCNP40Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI M684KTCCNP401), received between May 30, 2019 and Nov 24, 2025 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PAIN MAINLY AT NIGHT, ITCHING WHEN FALLING ASLEEP AND AT NIGHT, CONSTANT SWELLING OF THE KNEE, ALTHOUGH LESS THAN TWO YEARS AGO. SOME ALLERGIES WERE DETECTED DURING THE OPERATION: DUST, POLLEN, CHLORAMPHENICOL, PENICILLIN INTOLERANCE, AND ASPIRIN INTOLERANCE. ALLERGIES DETECTED IN TESTS PERFORMED FOR CONSTANT PAIN AND SWELLING OF THE KNEE (B)(6) 2025: POTASSIUM DICHROMATE, 2-BROMO-2-NITROPOP. 1.3, ISOPROPYLPHENOL, PARAPHENYLENEDIAMINE, LANOLIN, PROPOLIS. PATIENT SUFFERED THIS REACTION 6 YEARS. THE SURGICAL PROCEDURE IS UNCLEAR.

  Patient problems: Hypersensitivity/Allergic reaction; Pain; Swelling/ Edema

  MAUDE report 23633207 ↗
• InjuryJun 28, 2024Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING FEMUR / ASEPTIC LOOSENING TIBIA. SRNJR NUMBER: (B)(6). SIDE: L. GENDER: M.

  Patient problems: Insufficient Information

  MAUDE report 19638693 ↗
• InjuryApr 17, 2023Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. REVISION NJR NUMBER: 5057460. SIDE: L. PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE.

  Patient problems: Insufficient Information

  MAUDE report 16751257 ↗
• InjuryOct 19, 2022Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Failure of Implant

  MAUDE report 15635224 ↗
• InjuryMay 10, 2022Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. REVISION NJR NUMBER: 4846111. SIDE: R . PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Failure of Implant

  MAUDE report 14349175 ↗
• InjuryMar 16, 2021Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY REVISION NJR NUMBER: 4575430. SIDE: R. PRIMARY ASA: MILD DISEASE NOT INCAPACITATING COMPONENT NOT REVISED: ADVANCE ONLAY ALL POLY PATELLA 38MM TRIPEG PRODUCT ID: KPONTP38 LOT NO.: 15556871569625 MHRA REFERENCE NO: (B)(4).

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 11496112 ↗
• InjuryJun 25, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. COMPONENT NOT REVISED: ADVANCE ONLAY ALL POLY PATELLA 32MM TRIPEG PRODUCT ID: KPONTP32 LOT ID: 1654906. REVISION NJR NUMBER: 4477253. SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: No Information

  MAUDE report 10196663 ↗
• InjuryJun 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION SUBLUXATION. REVISION NJR NUMBER: 4359681. SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: No Information

  MAUDE report 10194440 ↗
• InjuryJun 24, 2020Unstable; Loss of Osseointegration; Malposition of Device; Unstable; Loss of Osseointegration; 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 10192146 ↗
• InjuryJun 24, 2020Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING FEMUR AND ASEPTIC LOOSENING TIBIA. REVISION NJR NUMBER: 4339248. SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: No Information

  MAUDE report 10189004 ↗
• InjuryJun 23, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. REVISION NJR NUMBER: 4459360. SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: No Information

  MAUDE report 10183987 ↗
• InjuryJun 22, 2020Unstable; Malposition of Device; Unstable; Malposition of Device

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY; MALALIGNMENT; STIFFNESS COMPONENT NOT REVISED: PATELL, REVISION NJR NUMBER: (B)(4), SIDE: L, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: No Information

  MAUDE report 10179835 ↗
• MalfunctionJun 26, 2019Malposition of Device; Malposition of Device

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO MALALIGNMENT; STIFFNESS. REVISION NJR NUMBER: (B)(4). SIDE: R. PRIMARY ASA: P2-MILD DISEASE NOT INCAPACITATING.

  Patient problems: Loss of Range of Motion

  MAUDE report 8736688 ↗
• InjuryJun 25, 2019Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Osteolysis

  MAUDE report 8732932 ↗
• InjuryMay 30, 2019Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY (LEFT). REVISION NJR NUMBER: (B)(4). PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: No Information

  MAUDE report 8656123 ↗