BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL AP HUMERAL STEM 12MM

    MDR report key: 2112770 · Received May 18, 2011

    Report

    Report Number
    1818910-2011-08942
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWS
    PMA / PMN Number
    K060874
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR BOTH OF THE REPORTED PART AND LOT NUMBER COMBINATIONS. PROVIDED INFO MARKED ON THE DEVICE EXPERIENCE REPORT IS MARKED 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 INFO PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT REVISED FOR INFECTION. ALL IMPLANTS REMOVED, CEMENT SPACER PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL AP HUMERAL STEM 12MM 87 KWS, HSD KWS DEPUY ORTHOPAEDICS, INC. NA E6CFD1

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention