BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL SHD DS HYL KEEL GLEN 44

    MDR report key: 3162563 · Received June 11, 2013

    Report

    Report Number
    1818910-2013-18611
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    KWT
    PMA / PMN Number
    PK905786
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    VISUAL EXAMINATION FOUND THE RETURNED DEVICE VERY WELL WORN; THE ARTICULATING SURFACE HAS WORN THROUGH INTO TWO PLACES AND APPROXIMATELY 1/3 OF THE MATERIAL IS MISSING FROM WEAR THROUGH AND FRACTURE. THE FINNED AREA OF THE COMPONENT IS DAMAGED; MATERIAL FOUND TO BE FLATTENED. FROM THE OBSERVED DAMAGE, IT¿S REASONABLE TO CONCLUDE CONFIRMATION OF THE LOOSENING. THE INVESTIGATION HAS DETERMINED THAT AT THE TIME OF DISTRIBUTION THIS DEVICE WAS MANUFACTURED FROM (B)(4) MATERIAL (B)(4). THIS DEVICE HAS BEEN IMPLANTED FOR 17 YEARS IN VIVO. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. REVIEW OF THE AS400 FOUND THIS PRODUCT CODE HAS BEEN INACTIVE/OBSOLETE 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 TO ADDRESS LOOSENING OF THE GLENOID COMPONENT. THE LOOSENING INTERFACE AND MANUFACTURER OF THE CEMENT USED AT THE TIME OF ORIGINAL IMPLANTATION ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263318 GLOBAL SHD DS HYL KEEL GLEN 44 GLENOID PROSTHESIS KWT 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC 564160004

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention