ADVANCE® KIMP312RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684KIMP312R1), received between Jun 20, 2019 and Apr 19, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

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

  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 19147710 ↗
• InjuryOct 13, 2021Unstable; Unstable

  ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. REVISION NJR NUMBER: (B)(4). SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENTS NOT REVISED: ADVANCE PRIMARY FEMORAL SIZE 3 RIGHT NONPOROUS PRODUCT NAME: KFTCNP3R, LOT NUMBER: 7484802. ADVANCE II COCR TIBIA BASE NONPOROUS SZ 3 STANDARD PRODUCT NAME: KTCCNP30, LOT NUMBER: 7350410.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12625078 ↗
• InjuryJun 20, 2019Unstable; Unstable

  ALLEGEDLY, RIGHT "PATELLA OA" IS REASON FOR REVISION, PAIN & INSTABILITY. POLY X 12MM WAS PULLED AND REPLACED WITH A 3X17MM, STRYKER PATELLA WAS IMPLANTED. COMPONENTS NOT REVISED: ADVANCE FEMUR SIZE 3 RIGHT KFTCPC3R LOT 038577450, ADVANCE TIB BASE SIZE 3 KTSSFM31 LOT 127503866, ADVANCE MODULAR KEEL SPKT0023 LOT 018484504, CANCELLOUS BONE SCREW 75520040 X2 LOT 028547359, CANCELLOUS BONE SCREW 75520025 X2 LOT 028551177 & 02851176.

  Patient problems: Pain

  MAUDE report 8716449 ↗