BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HIP

    MDR report key: 1972451 · Received January 26, 2011

    Report

    Report Number
    1818910-2011-01131
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    August 26, 2008
    Report Date
    December 22, 2021
    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
    MN, 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 THAT SOON AFTER THE IMPLANT, THE PATIENT SUFFERED FROM SEVERE PAIN. IT IS FURTHER ALLEGED THAT RADIOGRAPHIC IMAGES OF HER LEFT HIP REVEALED THAT THE CUP HAD SLIPPED TO A VERTICAL POSITION AND THAT SCLEROSIS DEVELOPED ON THE LATERAL ASPECT OF THE ACETABULUM "WHERE THE FEMORAL HEAD HAS BEEN IMPACTING IN THE BONY STRUCTURES AND NOT THE ACETABULUM.

    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 60 YR Female Required Intervention ASR UNI FEMORAL IMPL SIZE 39.| NA.| UNKNOWN HIP FEMORAL STEM.