ADVANCE® KFTCNP3LRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M684KFTCNP3L1), received between Aug 6, 2019 and Apr 17, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2023Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY/WEAR OF POLYETHYLENE COMPONENT REVISION NJR NUMBER: 5052592 SIDE: L PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Insufficient Information

  MAUDE report 16751313 ↗
• InjuryMay 11, 2022Insufficient 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.

  Patient problems: Bone Fracture(s)

  MAUDE report 14357534 ↗
• InjuryApr 13, 2021Fracture

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE. REVISION NJR NUMBER: (B)(4), SIDE: L, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING, MHRA REFERENCE NO: (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11656421 ↗
• InjuryNov 20, 2020Unstable; Migration; Unstable; Migration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISSOCIATION OF THE TIBIAL POLYETHYLENE. ADDITIONAL INFORMATION RECEIVED ON 09/02/2020 FROM (B)(6): CHANGING IMPLANT DATE , ADDING ORIGINAL HOSPITAL NAME , (B)(6) HOSPITAL NAME AND EXPLANT DATE. ADDITIONAL INFORMATION RECEIVED ON 09/03/2020 FROM (B)(6): CHANGING REASON FOR REVISION , PRODUCT AND LOT NUMBERS , IMPLANT AND EXPLANT DATE. ALLEGEDLY, PATIENT WAS REVISED DUE TO FEMUR HAD TIPPED INTO INTERNAL ROTATION. THIS IS THE FIRST PATIENT REVISION. SECOND REVISION HAS BEEN CAPTURED UNDER INCIDENT NUMBER: (B)(4). MHRA REFERENCE NO: (B)(4).

  Patient problems: No Information

  MAUDE report 10874895 ↗
• InjuryJun 29, 2020Malposition of Device; Malposition of Device

  ALLEGEDLY, PATIENT WAS REVISED DUE TO MALALIGNMENT AND STIFFNESS. REVISION NJR NUMBER: (B)(4); SIDE: L ; PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Loss of Range of Motion

  MAUDE report 10206980 ↗
• InjuryJun 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Unspecified Infection

  MAUDE report 10199854 ↗
• InjuryAug 6, 2019Break; Break

  ALLEGEDLY DURING THE REVISION SURGERY THE SURGEON FOUND OUT THAT THE MEDIAL POSTERIOR CONDYLE OF THE PRIMARY FEMUR COMPONENT WAS BROKEN. THE EXPOSED METAL PART BECAME SHARPED AND DUG DOWN INTO THE MEDIAL SIDE OF THE INSERT.

  Patient problems: No Information

  MAUDE report 8865599 ↗
• InjuryAug 6, 2019Break; Naturally Worn; Break; Naturally Worn

  ALLEGEDLY DURING THE REVISION SURGERY THE SURGEON FOUND OUT THAT THE MEDIAL POSTERIOR CONDYLE OF THE PRIMARY FEMUR COMPONENT WAS BROKEN. THE EXPOSED METAL PART BECAME SHARPED AND DUG DOWN INTO THE MEDIAL SIDE OF THE INSERT.

  Patient problems: No Information

  MAUDE report 8865592 ↗