ADVANCE® KIMP410RRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684KIMP410R1), received between Aug 6, 2019 and May 26, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Unstable” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2022Naturally Worn; Naturally Worn

  ALLEGEDLY, FRACTURE OF THE FEMORAL COMPONENT OF THE TKR, ADDITIONALLY THE TIBIAL INSERT HAD WEAR RESULTANT FROM THE FEMORAL IMPLANT FRACTURE, ALL COMPONENTS WERE REVISED (FEMORAL COMPONENT, INSERT AND TIBIA COMPONENT).

  Patient problems: Insufficient Information

  MAUDE report 14519183 ↗
• InjuryMay 10, 2022Unstable; Unstable

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

  Patient problems: Insufficient Information

  MAUDE report 14349214 ↗
• InjuryApr 20, 2021Unsealed Device Packaging; Unsealed Device Packaging

  ALLEGEDLY, AFTER OPENING THE PACKAGE OF THE LINER, THE NURSE FOUND THE INSIDE PACKAGE WAS NOT SEALED. THE PART WAS SUPPOSED TO BE SEALED INSIDE THE WHITE BAG FOR STERILIZATION PURPOSE TO AVOID CONTAMINATION. HOWEVER, THE PART INSIDE IS EXPOSED TO THE AIR DIRECTLY. THE STERILIZATION CANNOT BE GUARANTEED. ONCE BEING AWARE OF THE INCIDENT, DISTRIBUTOR STARTED TO PREPARE THE SPARED PART AT THE FIRST MOMENT. ALTHOUGH THE OPERATION WAS COMPLETED FINALLY, THE WHOLE PROCESS WAS DELAYED FOR MORE THAN 1.5 HOURS, WHICH MIGHT HAVE NEGATIVE EFFECTS TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11697764 ↗
• InjuryJun 25, 2020Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. COMPONENT NOT REVISED: ADVANCE ONLAY ALL POLY PATELLA 32MM TRIPEG PRODUCT ID : KPONTP32 LOT ID: 1654906. REVISION NJR NUMBER: 4477253. SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: No Information

  MAUDE report 10196668 ↗
• InjuryAug 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY THE PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: (B)(4). SIDE: R. PRIMARY ASA: P2- MILD DISEASE NOT INCAPACITATING. THE FOLLOWING COMPONENTS HAVE NO ALLEGED DEFICIENCY AND WERE NOT REVISED DURING THIS SURGERY: ADVANCE PRIMARY FEMORAL SIZE 4 RIGHT NONPOROUS KFTCNP4R, LOT # 1778404 QTY. 1; ADVANCE II COCR TIBIA BASE NONPOROUS SZ 4 STANDARD KTCCNP40, LOT # 1765223 QTY. 1; ADVANCE ONLAY ALL POLY PATELLA 32MM TRIPEG KPONTP32, LOT # 1780373 QTY. 1.

  Patient problems: Unspecified Infection

  MAUDE report 8865601 ↗