BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSET HV BONE CEMENT 40G

    MDR report key: 14218189 · Received April 27, 2022

    Report

    Report Number
    1818910-2022-07633
    Event Type
    Malfunction
    Date Received
    April 27, 2022
    Date of Event
    April 15, 2022
    Report Date
    April 27, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LOD
    UDI-DI
    10603295168331
    PMA / PMN Number
    K033563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 PRODUCT CODE 3092040, LOT NUMBER 9859816, AND NO NON-CONFORMANCES / MANUFACTURING IRREGULARITIES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CEMENT DID NOT SET UP PROPERLY. WAS NOT SET UP UNTIL 20 MINUTES AFTER INITIAL MIX. SURGICAL TECH REFUSED TO FOLLOW PROPER MIXING TECHNIQUE AS DIRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971172 SMARTSET HV BONE CEMENT 40G BONE CEMENT : BONE CEMENT LOD DEPUY ORTHOPAEDICS INC US 3092-040 9859816 10603295168331

    Patients

    Seq Age Sex Outcome Treatment
    1 Male