BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ADVANTAGE HUM HD 56X18

    MDR report key: 1020974 · Received March 26, 2008

    Report

    Report Number
    1818910-2008-00848
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 25, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWT
    PMA / PMN Number
    K984541
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED IMPLANTS BY A DEPUY WARSAW PRODUCT DEVELOPMENT ENGINEER CONFIRMED MINIMAL FRETTING INSIDE THE STEM. THE ENGINEER STATED, MINIMAL FRETTING IS EXPECTED IN ALL METAL MORSE TAPERS. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED BECAUSE, THE SHOULDER WAS STIFF DUE TO CHRONIC MASSIVE ROTATOR CUFF TEAR. UPON EXPOSURE, THE IMPLANTS APPEARED TO DISPLAY METAL FRETTING AT THE MORSE TAPER BETWEEN THE STEM AND THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL ADVANTAGE HUM HD 56X18 87KWT KWT DEPUY ORTHOPAEDICS, INC. NA U2RDD1

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention