ADVANCE® KIMP410LRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684KIMP410L1), received between Aug 6, 2019 and Aug 6, 2024 — 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. 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 6, 2024Naturally Worn; Naturally Worn

  ALLEGEDLY, PATIENT WENT INTO TKR REVISION DUE TO PAIN WITH THE INITIAL IMPLANT, FOUND IRREGULAR WEAR AND TEAR AT ODD PLACES.

  Patient problems: Insufficient Information

  MAUDE report 19919137 ↗
• InjuryApr 17, 2023Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. REVISION NJR NUMBER: 5057460. SIDE: L. PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE.

  Patient problems: Insufficient Information

  MAUDE report 16751289 ↗
• InjuryApr 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: 5053733. SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. PRODUCTS NOT REVISED: PRODUCT ID: LOT NUMBER: QTY: KFTCNN4L 29818984 1. KTCCNP41 111294968 1.

  Patient problems: Unspecified Infection

  MAUDE report 16725530 ↗
• InjuryJul 29, 2020Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT WAS REVISED DUE TO POSSIBLE INFECTION IN HIS LEFT SIDE AND POLY SWAP. PREVIOUS REVISION WAS CAPTURED UNDER THE INCIDENT NUMBER : 17100035.

  Patient problems: Unspecified Infection

  MAUDE report 10339963 ↗
• InjuryJun 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION SUBLUXATION. REVISION NJR NUMBER: 4359681. SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: No Information

  MAUDE report 10194479 ↗
• InjuryAug 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO STIFFNESS. REVISION NJR NUMBER: (B)(4). SIDE: L. PRIMARY ASA: P2-MILD DISEASE NOT INCAPACITATING. THE FOLLOWING COMPONENTS HAVE NO DEFICIENCY AND WERE NOT REVISED DURING THIS SURGERY: ADVANCE PRIMARY FEMORAL SIZE 4 LEFT NONPOROUS KFTCNP4L, LOT # 1497882 QTY. 1; ADVANCE II COCR TIBIA BASE NONPOROUS SZ 4 STANDARD KTCCNP40, LOT # NI QTY. 1.

  Patient problems: Neck Stiffness

  MAUDE report 8865645 ↗