BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SIZE 46

    MDR report key: 1983465 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-01543
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    December 1, 2010
    Report Date
    August 7, 2015
    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
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510(K) SUBMITTED AS DEPUY ORTHOPAEDICS SELLS A SIMILAR PRODUCT (OR THE SAME PRODUCT WITH A DIFFERENT PRODUCT CODE) IN THE US. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA AND THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE PT HAD PAIN ON THE RIGHT SIDE AND IS THEREBY HANDICAPPED. THERE IS AN UNUSUAL AMOUNT OF COBALT IN THE BLOOD, SO THE DOCTOR IS SUSPICIOUS OF METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SIZE 46 TOTAL HIP PROSTHESIS KWA DEPUY INTERNATIONAL, LTD. NA 2900364

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention