BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HIP

    MDR report key: 1945585 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-10203
    Event Type
    Injury
    Date Received
    December 30, 2010
    Report Date
    December 1, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    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 THAT LESS THAN THREE MONTHS AFTER HIS INITIAL SURGERY, THE PATIENT WAS FORCED TO UNDERGO REVISION SURGERY TO REMOVE HIS DEFECTIVE IMPLANT. IT IS FURTHER ALLEGED THAT THE PATIENT'S SURGEON REPLACED THE ASR IMPLANT WITH ANOTHER ASR HIP AND THE PATIENT CONTINUES TO EXPERIENCE PERSISTENT PAIN, HEARS NOISE EMANATING FORM HIP HOP DURING MOVEMENT, AND FEELS LIKE HIS HIP MOVES OUT OF PLACE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention