BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMK UNIVERSAL STEM 10 X 50MM

    MDR report key: 1800796 · Received August 10, 2010

    Report

    Report Number
    1818910-2010-05702
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    K864671
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE PRODUCTS TO EXAMINE. IT WAS NOTED THE PRODUCT WAS IMPLANTED FOR SIXTEEN YEARS PRIOR TO REVISION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS MODERATE POLY WEAR OF THE INSERT, SEVERE OSTEOLYSIS, AND LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMK UNIVERSAL STEM 10 X 50MM 87JWH JWH DEPUY ORTHOPAEDICS, INC. NA 905730

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention