ADVANCE® KFPSNP20Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684KFPSNP201), received between May 10, 2021 and Jan 23, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 18564653 ↗
• InjuryApr 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE. REVISION NJR NUMBER: (B)(4). 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 16726328 ↗
• InjuryJan 31, 2022Fracture

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE. PRODUCT NO REVISED: PART ID KPONTP35, ADVANCE ONLAY ALL POLY PATELLA 35MM TRIPEG, LOT 29792865, QTY 1. REVISION NJR NUMBER: (B)(4), SIDE: R, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Bone Fracture(s)

  MAUDE report 13400442 ↗
• InjuryMay 10, 2021Break; Break

  ALLEGEDLY, PATIENT WAS REVISED DUE TO IMPLANT FRACTURE. (B)(4). SIDE: L. PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE. (B)(6) REFERENCE NO: (B)(4).

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

  MAUDE report 11803413 ↗