BEUDAMED
    FDA Adverse Event Injury Summary report: N

    50MM METAL ON METAL SHELL

    MDR report key: 3864011 · Received June 10, 2014

    Report

    Report Number
    1818910-2014-20583
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 4, 2013
    Report Date
    May 14, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. REG. # 8010379
    Product Code
    KWA
    PMA / PMN Number
    PK001523
    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

    (B)(4). REVISED DUE TO ASEPTIC LOOSENING. ADDITIONAL INFORMATION REPORTS NIGHT PAIN, PAIN MEANS THE PATIENT CAN ONLY WALK AROUND THE HOUSE. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PROVIDED PRODUCT AND LOT COMBINATIONS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    REVISED DUE TO ASEPTIC LOOSENING. ADDITIONAL INFORMATION REPORTS NIGHT PAIN, PAIN MEANS THE PATIENT CAN ONLY WALK AROUND THE HOUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341204 50MM METAL ON METAL SHELL HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD. REG. # 8010379 XUF-36

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention