BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUMATCH M-SERIES SCREW, 23MM

    MDR report key: 3853544 · Received June 3, 2014

    Report

    Report Number
    1038671-2014-00179
    Event Type
    Injury
    Date Received
    June 3, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 28, 2014
    Manufacturer
    EXACTECH, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES ARE AWAITING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    A TOTAL HIP ARTHROPLASTY WAS REVISED APPROXIMATELY 14 YEARS POST-OPERATIVELY BECAUSE OF A FRACTURE IN THE MODULAR STEM PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323232 ACUMATCH M-SERIES SCREW, 23MM SCREW LPH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R