BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY FEMORAL HEAD

    MDR report key: 882849 · Received July 18, 2007

    Report

    Report Number
    1818910-2007-02293
    Event Type
    Injury
    Date Received
    July 18, 2007
    Date of Event
    June 27, 2007
    Report Date
    June 27, 2007
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. REVIEW OF DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PROD AND LOT CODES WERE UNAVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L INFO BE RECEIVED, THE COMPLAINT WILL BE RE-OPENED. DEPUY CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY FEMORAL HEAD TOTAL HIP REPLACEMENT KWY DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention