BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK BONE SCREW

    MDR report key: 1172056 · Received September 22, 2008

    Report

    Report Number
    1818910-2008-04105
    Event Type
    Injury
    Date Received
    September 22, 2008
    Report Date
    August 23, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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.

    Description of Event or Problem · 1

    EXAMINATION OF RECEIVED PT X-RAYS RECEIVED IN 2008, NOTES A BONE SCREW THAT APPEARS LOOSE WITHIN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK BONE SCREW TOTAL HIP PROSTHESIS HWC DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female