ADVANCE® KFTCNP3RRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI M684KFTCNP3R1), received between Jun 25, 2019 and Apr 19, 2024 — classified as 12 injuries.

The most frequently reported specific device problem is “Unstable” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2024Loss of Osseointegration; Loss of Osseointegration

  ALLEGEDLY, THE PATIENT WAS DIAGNOSED WITH RADIOLOGY. EVIDENT LOOSENING OF THE PROSTHESIS WAS DETECTED, THE TIBIAL BASE WAS REPLACED. THE INITIAL IMPLANTATION WAS PERFORMED IN 2015. FIRST REVISION: IT WAS DETECTED SHORTLY AFTER IMPLANTATION THAT THERE WAS INFECTION AND AN INSERT CHANGE WAS PERFORMED. PE WAS NOT FIRMLY ATTACHED TO THE TIBIAL COMPONENT AS INTENDED, BUT BECAME DETACHED FROM IT. AS A RESULT, THERE WAS WEAR OF THE UNDERSIDE OF THE INSERT WITH POLYETHYLENE GRANULOMAS. THERE WERE POLYETHYLENE GRANULOMAS THROUGHOUT THE JOINT AND COMPLETE LOOSENING OF THE PROSTHESIS. THE JOINT WAS RECONSTRUCTED WITH A COMPLEX COUPLED, MODULAR, STEM-GUIDED PROSTHESIS AND ALL GRANULOMAS WERE REMOVED IN APPROXIMATELY 3 HOURS OF REVISION SURGERY. THE EXPLANTS WERE GIVEN TO THE PATIENT: PRODUCT ID: KIMP312R ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 3 RIGHT 12MM / LOT NO.: 1687317/ QTY: (B)(4). PRODUCT ID: KFTCNP3R ADVANCE® PRIMARY FEMORAL SIZE 3 RIGHT NONPOROUS / LOT NO.: 1707334/ QTY: (B)(4). PRODUCT ID: KTCCNP30 ADVANCE® II COCR TIBIAL BASE NONPOROUS SZ 3 STANDARD/ LOT NO.: 1644600/ QTY: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19146252 ↗
• InjuryFeb 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, LYSIS FEMUR/PERIPROSTHETIC FRACTURE SIDE: R REVISION NJR: (B)(6). GENDER: F EXPLANTED: FEMORAL COMPONENT, TIBIAL COMPONENT, TIBIAL LINER

  Patient problems: Bone Fracture(s); Osteolysis

  MAUDE report 18796415 ↗
• InjuryFeb 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, OTHER. SIDE: R. REVISION NJR: 854772. GENDER: F. EXPLANTED: ALL.

  Patient problems: Insufficient Information

  MAUDE report 18796292 ↗
• InjuryAug 3, 2022Fracture

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE. REVISION NJR NUMBER: (B)(4). SIDE: R . PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENT NOT REVISED: PRODUCT: ADVANCE II MEDIAL PIVOT TIBIA INSERT SZ 3 RIGHT 10MM PRODUCT ID: KIMP310R LOT # : 125303897 QTY: 1.

  Patient problems: Bone Fracture(s)

  MAUDE report 15160770 ↗
• InjuryMay 12, 2021Fracture

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE. (B)(4). SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. (B)(6) REFERENCE NO: (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 11812925 ↗
• InjuryDec 4, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING TIBIA; INSTABILITY; WEAR OF POLYETHYLENE COMPONENT; PROGRESSIVE ARTHRITIS. REVISION NJR NUMBER: (B)(4). SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. (B)(6) REFERENCE NO: (B)(4).

  Patient problems: Arthritis

  MAUDE report 10945709 ↗
• InjuryJun 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PERIPROSTHETICFRACTURE. COMPONENT NOT REVISED: ADVANCE II COCR TIBIA BASE NONPOROUS SZ 3 STANDARD PRODUCT ID: KTCCNP30 LOT ID: 1736502. ADVANCE II MEDIAL PIVOT TIBIA INSERT SZ 3 RIGHT 12MM PRODUCT ID: KIMP312R LOT ID: 1512029. REVISION NJR NUMBER: 4373718. SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Bone Fracture(s)

  MAUDE report 10207157 ↗
• InjuryJun 26, 2020Unstable; Unstable

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

  Patient problems: No Information

  MAUDE report 10203386 ↗
• InjuryJun 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI PROSTHETIC FRACTURE. COMPONENT NOT REVISED: ADVANCE II COCR TIBIA BASE NONPOROUS SZ 3 STANDARD PRODUCT ID: KTCCNP30 LOT #: 020153197. REVISION NJR NUMBER: 4348091. SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Bone Fracture(s)

  MAUDE report 10184206 ↗
• InjuryJun 25, 2019Unstable; Malposition of Device; Device Dislodged or Dislocated; Unstable; Malposition of Device; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION SUBLUXATION; INSTABILITY; MALALIGNMENT REVISION NJR NUMBER: (B)(4), SIDE: R, PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE.

  Patient problems: No Information

  MAUDE report 8732940 ↗
• InjuryJun 25, 2019Unstable; Malposition of Device; Device Dislodged or Dislocated; Unstable; Malposition of Device; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION SUBLUXATION; INSTABILITY; MALALIGNMENT REVISION NJR NUMBER: (B)(4). SIDE: R. PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE.

  Patient problems: No Information

  MAUDE report 8732939 ↗
• InjuryJun 25, 2019Unstable; Malposition of Device; Device Dislodged or Dislocated; Unstable; Malposition of Device; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION SUBLUXATION; INSTABILITY; MALALIGNMENT REVISION NJR NUMBER: (B)(6). SIDE: R. PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE.

  Patient problems: No Information

  MAUDE report 8732937 ↗