BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTSET HV BONE CEMENT 40G

    MDR report key: 14914589 · Received July 5, 2022

    Report

    Report Number
    1818910-2022-12270
    Event Type
    Injury
    Date Received
    July 5, 2022
    Date of Event
    November 4, 2020
    Report Date
    July 5, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    UDI-DI
    10603295168331
    PMA / PMN Number
    K033563
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 3092040/8341093 NUMBER, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED.

    Description of Event or Problem · 0

    PATIENT RECEIVED A LEFT PRIMARY ATTUNE TO TREAT DJD. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A LEFT KNEE REVISION TO TREAT PAIN, SWELLING, AND WALKING DIFFICULTY SECONDARY TO SUSPECTED TIBIAL TRAY LOOSENING. UPON ENTERING THE JOINT, THE SURGEON EVACUATED A MILD EFFUSION AND PATHOLOGY CONFIRMED NO INFECTION. THE TIBIAL TRAY WAS GROSSLY LOOSE AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THE FEMORAL COMPONENT WAS WELL-FIXED BUT REVISED TO ACCOMMODATE THE REVISION KNEE. THE PATELLA WAS WELL-FIXED AND RETAINED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE PATIENT RECEIVED A COMPETITOR CONSTRUCT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2017 DOR: (B)(6) 2020 LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163228 SMARTSET HV BONE CEMENT 40G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 3092-040 8341093 10603295168331

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention ATTUNE CR FEM LT SZ 4 NAR CEM.| ATTUNE CR RP INSRT SZ 4 6MM.| ATTUNE MEDIAL ANAT PAT 32MM.| ATTUNE RP TIB BASE SZ 2 CEM.| SMARTSET GHV GENTAMICIN 40G.| SMARTSET HV BONE CEMENT 40G.