BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP SYSTEM

    MDR report key: 183177 · Received August 20, 1998

    Report

    Report Number
    1644408-1998-00005
    Event Type
    Other
    Date Received
    August 20, 1998
    Date of Event
    April 28, 1998
    Report Date
    August 19, 1998
    Manufacturer
    ENCORE ORTHOPEDICS, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    LOCKING RING IN ACETABULAR SHELL BECAME DAMAGED INTRAOPERATIVELY DURING THE INSERTION OF THE TRIAL LINER AND ACETABULAR LINER. WHEN THE ACETABULAR LINER WOULD NOT LOCK IN SHELL, SURGEON NOTED THAT THE LOCKING RING HAD TWISTED AND DAMAGED THE ACETABULAR LINER. NO BACKUP INVENTORY WAS AVAILABLE AND SURGERY WAS DELAYED 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP SYSTEM Implant ACETABULAR LINER LPH ENCORE ORTHOPEDICS, INC. * 159491

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other