BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL EUT 28MM 46OD (ULTAMET)

    MDR report key: 1415100 · Received July 16, 2009

    Report

    Report Number
    1818910-2009-03717
    Event Type
    Injury
    Date Received
    July 16, 2009
    Report Date
    June 16, 2009
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K023786
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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

    DURING THE SURGERY, METALLOSIS WAS NOTED AROUND THE CUP. THE LINER WAS FOUND DISASSEMBLED EVEN THOUGH THE DOCTOR DID NOT USE THE REMOVER. ACCORDING TO THE DOCTOR, IT WAS FOUND BLACK ESPECIALLY BETWEEN THE LINER AND CUP, AND THE CUP AND ACETABULUM. THE BACK OF THE LINER HAS THE SCRATCH, WHICH MIGHT BE MADE BY THE SCREW HEAD. THE CUP AND SCREWS WERE MANUFACTURED BY JMM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL EUT 28MM 46OD (ULTAMET) 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2127418

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention