BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ASR HEAD

    MDR report key: 1772342 · Received July 23, 2010

    Report

    Report Number
    1818910-2010-05188
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    May 26, 2010
    Report Date
    April 22, 2026
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO NEW INFORMATION TO REPORT AT THIS TIME. PER FDA REQUEST, THIS FOLLOW-UP 1 IS BEING SUBMITTED TO FILL THE GAP IN REPORT SEQUENCE NUMBERS.

    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

    REVISION DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594690 UNKNOWN ASR HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED (METAL UNCEMENTED ACETABULAR COMPONENT) KWA DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Unknown Required Intervention