BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSET HV BONE CEMENT 40G

    MDR report key: 13203748 · Received January 10, 2022

    Report

    Report Number
    1818910-2022-00491
    Event Type
    Malfunction
    Date Received
    January 10, 2022
    Date of Event
    January 1, 2021
    Report Date
    January 10, 2022
    Manufacturer
    DEPUY CMW - 9610921
    Product Code
    MBB
    UDI-DI
    10603295168331
    PMA / PMN Number
    K033563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4), TRADE NAME GENTAMICIN SULPHATE, ACTIVE INGREDIENT(S) GENTAMICIN SULPHATE, DOSAGE FORM - POWDER, STRENGTH 1.0G ACTIVE IN OUR CEMENTS. 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 (NC SEARCH) WAS PERFORMED FOR THE FINISHED DEVICE 3092040, LOT 9671763, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES RELATED TO THE MALFUNCTION WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CEMENT VIAL WAS BROKEN TO INTRODUCE INTO THE POWER AND SHARDS ENTERED THE BOWL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794282 SMARTSET HV BONE CEMENT 40G BONE CEMENT : BONE CEMENT MBB DEPUY CMW - 9610921 3092-040 9671763 10603295168331

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SMARTSET HV BONE CEMENT 40G| SMARTSET HV BONE CEMENT 40G