BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACETABULAR TRIAL IMPACTOR

    MDR report key: 780833 · Received November 10, 2006

    Report

    Report Number
    MW1040912
    Event Type
    Malfunction
    Date Received
    November 10, 2006
    Date of Event
    November 3, 2006
    Report Date
    November 10, 2006
    Manufacturer
    SMITH & NEPHEW PLC ADS
    Product Code
    KIL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GRAY PLASTIC THREAD STOP BROKE INTO 3 PIECES DURING TRIAL INSERTION. DEVICE IS USED WITH A MALLET TO IMPACT ACETABULAR TRIAL INTO ACETABULUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACETABULAR TRIAL IMPACTOR * KIL SMITH & NEPHEW PLC ADS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR