BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HIP

    MDR report key: 2011443 · Received March 4, 2011

    Report

    Report Number
    1818910-2011-03647
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    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
    VA, 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 DEVICE FAILED TO ACHIEVE PROPER BONE INGROWTH INTO THE CUP AND THUS FAILED TO ACHIEVE PROPER FIXATION. IT IS FURTHER ALLEGED THAT THE DEVICE GENERATED EXCESSIVE METAL DEBRIS AND/OR CAUSED BONE FRACTURES.

    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 Female Required Intervention NA.