BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL AP HUMERAL HD 52X15 ECC

    MDR report key: 2141261 · Received June 22, 2011

    Report

    Report Number
    1818910-2011-11190
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 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
    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 PT COMPLAINED OF PAIN AND RANGE OF MOTION, COMPONENTS WERE WELL FIXED AND IN GOOD POSITION. THE SURGEON PERFORMED SIGNIFICANT SOFT TISSUE RELEASES AND IMPLANTED A GLENOID COMPONENT, REMOVED THE HEAD, AND REPLACED WITH A SMALLER SIZE. THE INVESTIGATION COULD NOT 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 WAS REVISED TO ADDRESS PAIN AND LIMITED ROM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL AP HUMERAL HD 52X15 ECC 87KWS 87HSD KWS DEPUY ORTHOPAEDICS, INC. NA EB6MS1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention