BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP 45MM

    MDR report key: 1801252 · Received August 11, 2010

    Report

    Report Number
    1818910-2010-05139
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    June 30, 2010
    Report Date
    April 22, 2026
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE UNITED STATES UNDER A DIFFERENT PART NUMBER. 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

    REVISION DUE TO PT COMPLAINING OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP 45MM TOTAL HIP REPLACEMENT JDI DEPUY INTERNATIONAL, LTD. NA 1230170

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention