ADVANCE® KIMP412RRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684KIMP412R1), received between Jun 18, 2019 and Nov 24, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. 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 5 most recent of 5 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 23633209 ↗
• InjuryJul 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ALLEGEDLY, PATIENT WAS REVISED DUE TO RIGHT POLY LOOSENING, POSSIBLE INFECTION , POLY SWAP AND IT DOES NOT LOCKED IN. PREVIOUS REVISION WAS CAPTURED UNDER THE INCIDENT NUMBER : 17100035.

  Patient problems: Unspecified Infection

  MAUDE report 10339890 ↗
• InjuryMar 10, 2020Loosening of Implant Not Related to Bone-Ingrowth

  ALLEGEDLY, PATIENT HAS PAIN ON RIGHT KNEE AND ON FILM THERE APPEARS TO BE SIGNS OF IMPLANT LOOSENING. ALL IMPLANTS WERE REMOVED AND REPLACED WITH ODC IMPLANTS.

  Patient problems: Pain

  MAUDE report 9811884 ↗
• InjuryOct 3, 2019Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PAIN ''SOME INSTABILITY'' OF AN ADVANCE POLY INSERT.

  Patient problems: Pain

  MAUDE report 9150832 ↗
• InjuryJun 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, ANTERIOR KNEE PAIN ON STAIRS. RIGHT. POLY WAS REMOVED AND REPLACED WITH A 14MM, 41 PATELLA WAS IMPLANTED. COMPONENTS NOT REVISED: KTCCNP40 ADVANCE TIB BASE SIZE 4, LOT # 025186877. KFTCNP47 ADVANCE FEMUR SIZE 4 RIGHT, LOT # 025161232.

  Patient problems: Pain

  MAUDE report 8708770 ↗