ADVANCE® KFTCNP4RRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684KFTCNP4R1), received between Jun 22, 2020 and Aug 4, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Unstable” (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

Recent adverse event reports

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

• InjuryAug 4, 2022Premature Discharge of Battery; Overfill; Premature Discharge of Battery; Overfill

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

  Patient problems: Osteolysis

  MAUDE report 15169822 ↗
• InjuryMay 10, 2022Unstable; Unstable

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

  Patient problems: Failure of Implant

  MAUDE report 14349155 ↗
• InjuryMar 8, 2022Break; Break

  ALLEGEDLY, FRACTURE OF THE FEMORAL COMPONENT OF THE TKR, ADDITIONALLY THE TIBIAL COMPONENT HAD WEAR FROM THE FEMORAL FRACTURE, ALL COMPONENTS WERE REVISED.

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

  MAUDE report 13690645 ↗
• InjuryDec 15, 2021Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. REVISION NJR NUMBER: (B)(4), SIDE: R , PRIMARY ASA: P1 - FIT AND HEALTHY.

  Patient problems: Insufficient Information

  MAUDE report 13009413 ↗
• 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11496202 ↗
• InjuryJun 22, 2020Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING FEMUR; ASEPTIC LOOSENING TIBIA COMPONENT NOT REVISED: PATELLA, REVISION NJR NUMBER: 4481492, SIDE: R, PRIMARY ASA: P1 - FIT AND HEALTHY.

  Patient problems: No Information

  MAUDE report 10179165 ↗