BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 41

    MDR report key: 1872934 · Received October 14, 2010

    Report

    Report Number
    1818910-2010-06767
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    September 14, 2010
    Report Date
    April 2, 2026
    Manufacturer
    DEPUY INTL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    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

    PT REVISED FOR PAIN, LOOSE CUP, METALLOSIS, REMOVED CYST, NO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 41 87 KWA KWA DEPUY INTL, LTD. NA 2746948

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention