BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ADVANTAGE HUM HD 48X18

    MDR report key: 2971424 · Received February 21, 2013

    Report

    Report Number
    1818910-2013-12648
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    3006356043 JOHNSON & JOHNSON MEDICAL (DEPUY - SUZH
    Product Code
    KWT
    PMA / PMN Number
    PK984541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX D. TERRITORY OFFICE COMMUNICATED NO ADDITIONAL INFORMATION IS AVAILABLE. PROVIDED INFORMATION STATES THE SHOULDER JOINT WAS LOOSE AND DISLOCATING, ALL IMPLANTS WERE WELL FIXED; JUST NEEDED A THICKER HEAD TO FILL UP THE JOINT SPACE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED BECAUSE, THE SHOULDER JOINT WAS LOOSE AND DISLOCATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76912 GLOBAL ADVANTAGE HUM HD 48X18 HUMERAL HEAD KWT 3006356043 JOHNSON & JOHNSON MEDICAL (DEPUY - SUZH D12072802

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention