BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASR ACETABULAR IMPLANT 58

    MDR report key: 2183530 · Received June 22, 2011

    Report

    Report Number
    1818910-2011-10821
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 15, 2011
    Report Date
    October 30, 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
    UP
    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 TO ADDRESS DISLOCATION AND PAIN SECONDARY TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR IMPLANT 58 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2587191

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention