BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTALAC ACET CUP 42X32

    MDR report key: 767774 · Received October 3, 2006

    Report

    Report Number
    1818910-2006-03132
    Event Type
    Injury
    Date Received
    October 3, 2006
    Date of Event
    September 3, 2006
    Report Date
    September 3, 2006
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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

    PATIENT REVISED DUE TO DISASSOCIATION OF CUP FROM CEMENT, LOOSENING, AND OSTEOLYSIS FOUND INOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROSTALAC ACET CUP 42X32 TEMPORARY ANTIBIOTIC SPACER KBW DEPUY ORTHOPAEDICS, INC. NA A13BY1000

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention