BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HIP

    MDR report key: 1984418 · Received January 27, 2011

    Report

    Report Number
    1818910-2011-01143
    Event Type
    Injury
    Date Received
    January 27, 2011
    Report Date
    December 28, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    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

    LITIGATION PAPERS ALLEGE THE BILATERAL PT BEGAN SUFFERING FROM DISCOMFORT AND PAIN IN HER HIPS, GROIN, THIGHS AND BACK IN THE FIVE YEARS FOLLOWING HER HIP REPLACEMENT. IT IS FURTHER ALLEGED THAT SHE NOTICED AN AUDIBLE POPPING SOUND WHILE WALKING. NO REPORTED REVISION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HIP 87KWA KWA DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention