BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR IMPLANT 50

    MDR report key: 2073552 · Received April 26, 2011

    Report

    Report Number
    1818910-2011-06772
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 14, 2026
    Manufacturer
    DEPUY INTL. LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    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

    THE PT IS SCHEDULED FOR AN ASR REVISION SURGERY TO ADDRESS ALVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 50 87KWA KWA DEPUY INTL. LTD. NA 2386871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention