ADVANCE® KFTCNP5RRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684KFTCNP5R1), received between Jun 25, 2019 and Sep 7, 2022 — classified as 6 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 16, 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.

• InjurySep 7, 2022Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: 4902054. SIDE: R . PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Unspecified Infection

  MAUDE report 15374568 ↗
• InjuryMay 11, 2022Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE. REVISION NJR NUMBER: (B)(4), SIDE: R, PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE. THE PRODUCT KPON38SP, ADVANCE® ONLAY ALL-POLY PATELLA 38MM SINGLE PEG WAS NOT REVISED.

  Patient problems: Bone Fracture(s)

  MAUDE report 14356975 ↗
• InjuryOct 8, 2020Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING FEMUR AND OTHER INDICATION FOR REVISION REVISION NJR NUMBER:(B)(4). SIDE:R PRIMARY ASA: P4 - LIFE THREATENING DISEASE

  Patient problems: No Information

  MAUDE report 10649221 ↗
• InjuryJun 24, 2020Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING FEMUR AND PAIN. REVISION NJR NUMBER: 4403166. SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Pain

  MAUDE report 10190888 ↗
• InjuryJun 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO STIFFNESS. COMPONENTS NOT REVISED: ADVANCE II COCR TIBIA BASE NONPOROUS SZ 5 STANDARD PRODUCT ID: KTCCNP50 LOT ID: 087465508. ADVANCE ONLAY ALL POLY PATELLA 38MM TRIPEG PRODUCT ID: KPONTP38 PRODUCT ID: 046332811. REVISION NJR NUMBER: 1058353. SIDE: R. PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE.

  Patient problems: Loss of Range of Motion

  MAUDE report 10184484 ↗
• InjuryJun 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

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

  Patient problems: Loss of Range of Motion

  MAUDE report 8732925 ↗