BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL ADVANTAGE PC STEM 12MM

    MDR report key: 1892450 · Received November 3, 2010

    Report

    Report Number
    1818910-2010-07783
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    JOHNSON & JOHNSON MEDICAL (DEPUY-SUZHOU) LTD.
    Product Code
    MBF
    PMA / PMN Number
    K011047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. PROVIDED INFO STATES THE COMPONENT WAS SEATED TOO HIGH; RE-IMPLANTED PRIMARY COMPONENTS AND SEATED PROPERLY. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PROD CONTRIBUTION TO THE REPORTED EVENT WITH THE INFO PROVIDED. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY 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 TO ADDRESS A STEM THAT WAS SEATED TOO HIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL ADVANTAGE PC STEM 12MM 87MBF; 87KWS MBF JOHNSON & JOHNSON MEDICAL (DEPUY-SUZHOU) LTD. NA D85A81000

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention