BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ADVANTAGE ECC HD 56X18

    MDR report key: 3113529 · Received May 15, 2013

    Report

    Report Number
    1818910-2013-17117
    Event Type
    Injury
    Date Received
    May 15, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    3006356043 JOHNSON & JOHNSON MEDICAL (DEPUY - SUZH
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. PROVIDED INFORMATION STATES THE HEAD IMPLANTED WAS TOO LARGE WHICH CAUSED STIFFNESS AND LACK OF RANGE OF MOTION; REVISION SURGERY DOWNSIZED HEAD. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED BECAUSE THE ORIGINAL HEAD IMPLANTED WAS TOO LARGE, WHICH CAUSED STIFFNESS AND LACK OF RANGE OF MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214786 GLOBAL ADVANTAGE ECC HD 56X18 HUMERAL HEAD KWS 3006356043 JOHNSON & JOHNSON MEDICAL (DEPUY - SUZH D10071658

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention