BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ADVANTAGE HUM HD 48X18

    MDR report key: 3030461 · Received April 2, 2013

    Report

    Report Number
    1818910-2013-14755
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWT
    PMA / PMN Number
    PK984541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES AND X-RAYS ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR BOTH OF THE REPORTED PART AND LOT NUMBER COMBINATIONS. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX C. NO ADDITIONAL INFORMATION OBTAINED. IT IS MARKED ON THE DEVICE EXPERIENCE REPORT THAT THE PRODUCTS ARE NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR CONTRIBUTING TO THE REPORTED EVENT. 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

    THE PATIENT WAS REVISED BECAUSE OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134722 GLOBAL ADVANTAGE HUM HD 48X18 SHOULDER REPLACEMENT KWT 1818910 DEPUY ORTHOPAEDICS, INC. C68DS1000

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention