ADVANCE® KFTCNN4RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684KFTCNN4R1), received between Jun 25, 2020 and Nov 24, 2025 — classified as 2 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 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 23633210 ↗
• 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 10196656 ↗