ADVANCE® KIMP310LRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M684KIMP310L1), received between Jan 17, 2020 and Jul 18, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR INDEX NO: (B)(4). SIDE: L. NON REVISED PRODUCTS: PRODUCT ID: KFTCNP3L ADVANCE® PRIMARY FEMORAL SIZE 3 LEFT NONPOROUS/ LOT NUMBER: 1600497/ QTY: 1. PRODUCT ID: KPONTP32 ADVANCE® ONLAY ALL-POLY PATELLA 32MM TRI-PEG/ LOT NUMBER: 1594725/ QTY: 1. PRODUCT ID: KTTINP31 ADVANCE II MODULAR TITANIUM TIBIA BASE SZ 3+ NONPOROUS/ LOT NUMBER: 0901195804/ QTY: 1. PRODUCT ID: KSP14100 ADVANCE® CANAL FILLING STEM EXTENSION 15MM X 100MM/ LOT NUMBER: 049855338/ QTY: 1. PRODUCT ID: KTAGB410 ADVANCE® TIBIAL BLOCK AUGMENT SIZE 4/3+ X 10MM NONPOROUS/ LOT NUMBER: 127495301/ QTY: 1.

  Patient problems: Unspecified Infection

  MAUDE report 19778479 ↗
• InjuryApr 6, 2022Difficult to Insert; Difficult to Insert

  ALLEGEDLY, THE PATIENT'S KNEE JOINT WAS WORN AND MEDIAL, THE IMPLANTING PHYSICIAN TRIED TO ASSEMBLE THE INSERT (LOT.1881643), BUT FAILED; EVEN IF REPEATED ATTEMPTS STILL DO NOT WORK. ONCE BEING AWARE OF THE INCIDENT, THE IMPLANTING PHYSICIAN SWITCHED TO ANOTHER PRODUCT(LOT.1878191) IMMEDIATELY. ALTHOUGH THE OPERATION WAS COMPLETED FINALLY, THE WHOLE PROCESS WAS DELAYED FOR ABOUT 40 MINS.

  Patient problems: Joint Laxity

  MAUDE report 14025384 ↗
• InjuryNov 7, 2021Difficult to Insert; Difficult to Insert

  ALLEGEDLY, THE PATIENT'S KNEE JOINT WAS WORN AND MEDIAL, THE IMPLANTING PHYSICIAN TRIED TO ASSEMBLE THE INSERT, BUT FAILED; EVEN IF REPEATED ATTEMPTS STILL DO NOT WORK. AND THE METHOD OF DISLOCATION OF FEMUR WAS NOT EFFECTIVE. ONCE BEING AWARE OF THE INCIDENT, THE IMPLANTING PHYSICIAN SWITCHED TO ANOTHER PRODUCT IMMEDIATELY. ALTHOUGH THE OPERATION WAS COMPLETED FINALLY, THE WHOLE PROCESS WAS DELAYED FOR ABOUT 30 MINS. ADDITIONAL INFORMATION 27-OCT-2021: ANOTHER INSERT (SAME PART/SAME LOT) WAS SUCCESSFULLY IMPLANTED. A PART FROM THIS SAME PART/LOT WILL BE RETURNED FOR ANALYSIS. BASED ON SALES DATA FROM (B)(4), 2 PARTS WITH THIS SAME PART/LOT HAVE BEEN SUCCESSFULLY IMPLANTED. ONE IS INVOLVED IN THIS COMPLAINT.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 12756310 ↗
• 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 10207071 ↗
• InjuryJun 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: 4478100. SIDE: L. PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE.

  Patient problems: Unspecified Infection

  MAUDE report 10206024 ↗
• InjuryJun 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: 4356191. SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Unspecified Infection

  MAUDE report 10199945 ↗
• MalfunctionMar 24, 2020Difficult to Insert; Difficult to Insert

  ALLEGEDLY, WHEN POSITIONING THE INSERT, IT WOULD NOT SEAT INTO THE TIBIAL BASE AND THIS GENERATED A TIBIAL BASE DEFORMITY.

  Patient problems: No Information

  MAUDE report 9873399 ↗
• InjuryJan 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, MECHANICAL LOOSENING OF TIBIA AND PATELLA FEMORAL PAIN.

  Patient problems: Pain

  MAUDE report 9601512 ↗