BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREC O/L INS 28MM 10_P2

    MDR report key: 145884 · Received January 23, 1998

    Report

    Report Number
    2219689-1998-00038
    Event Type
    Malfunction
    Date Received
    January 23, 1998
    Report Date
    January 22, 1998
    Manufacturer
    HOWMEDICA INC.
    Product Code
    KWB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVALUATION: THE EVALUATION RESULTS VERIFIED THE REPORTED EVENT. A DESIGN CHANGE WAS INCORPORATED IN 12/1996 TO REDUCE OR ELIMINATE THIS CONDITION. THE INSERT OF THIS EVENT WAS MANUFACTURED IN 10/1996.

    Description of Event or Problem · 1

    THE SURGEON DETERMINED THAT THERE WAS A ROTATIONAL MOVEMENT OF APPROX 1/2 MM AFTER IMPACTING THE INSERT. THE INSERT WAS REMOVED AND ANOTHER INSERT WAS USED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREC O/L INS 28MM 10_P2 Implant IMPLANT KWB HOWMEDICA INC. NA URZY

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other