ADVANCE® KTCCNP50Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684KTCCNP501), received between Jun 27, 2019 and Dec 28, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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.

• InjuryDec 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PRIMARY NJRINDEXNO, 2759086 FROM UKNJR DATA EXTRACT. MALE PATIENT UNDERWENT TKA ON (B)(6) 2017 AND WAS IMPLANTED WITH ADVANCE PRIMARY FEMORAL. PATIENT WAS REVISED ON (B)(6) 2023 DUE TO INFECTION. FEMORAL COMPONENT, TIBIAL COMPONENT, TIBIAL LINER ALL REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 18411035 ↗
• InjuryApr 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: (B)(6). SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. PRODUCT NO REVISED: PRODUCT ID: KFTCNP5R, ADVANCE PRIMARY FEMORAL SIZE 5 RIGHT NONPOROUS, LOT: 1658788, QTY: 1.

  Patient problems: Unspecified Infection

  MAUDE report 16725859 ↗
• InjurySep 7, 2022Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 15374627 ↗
• InjuryJul 28, 2021Material Too Rigid or Stiff

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

  Patient problems: Loss of Range of Motion

  MAUDE report 12240207 ↗
• InjuryJun 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  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 10191605 ↗
• InjuryJun 27, 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)(6). SIDE: R. PRIMARY ASA: P2-MILD DISEASE NOT INCAPACITATING.

  Patient problems: Loss of Range of Motion

  MAUDE report 8740667 ↗