BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET HV BONE CEMENT 40G

    MDR report key: 9401068 · Received December 3, 2019

    Report

    Report Number
    1818910-2019-119473
    Event Type
    Injury
    Date Received
    December 3, 2019
    Date of Event
    February 26, 2019
    Report Date
    November 6, 2019
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    LOD
    UDI-DI
    10603295168331
    PMA / PMN Number
    K023012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT A DHR (DEVICE HISTORY RECORD) REVIEW ((B)(4)) DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE REPORTED LOT NUMBER (8151376). PATIENT CODE: NO CODE AVAILABLE ((B)(4)) IS USED TO CAPTURE JOINT INSTABILITY AND MEDICAL DEVICE REMOVAL.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. OCCUPATION IS A NON-HEALTHCARE PROFESSIONAL. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, SWELLING, MILD FLEXION INSTABILITY, AND PAIN. THE SURGEON INDICATED THE TIBIAL COMPONENT WAS COMPLETELY DE-BONDED AT THE CEMENT/IMPLANT INTERFACE, AND WELL-FIXED TO THE PROXIMAL TIBIA. HE DID NOT SPEAK TO THE STATE OF THE FEMORAL COMPONENT THOUGH IT WAS REVISED. THE SURGEON INDICATED THE PATELLAR COMPONENT WAS TRACKING CENTRAL AND WAS REVISED. THE PATIENT WAS IMPLANTED WITH ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 2. THERE WERE NO COMPLICATIONS REPORTED WITH THE PROCEDURE. DOI: (B)(6) 2015; DOR: (B)(6) 2019; (LT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199898 SMARTSET HV BONE CEMENT 40G BONE CEMENT : BONE CEMENT LOD DEPUY CMW - 9610921 3092-040 8151376 10603295168331

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention