BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP SYSTEM ACETABULAR SHELL

    MDR report key: 86449 · Received April 25, 1997

    Report

    Report Number
    1644408-1997-00003
    Event Type
    Other
    Date Received
    April 25, 1997
    Date of Event
    April 22, 1997
    Report Date
    April 25, 1997
    Manufacturer
    ENCORE ORTHOPEDICS, INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURATION OF SURGERY WAS EXTENDED. LOCKING RING OF ACETABULAR SHELL WAS DAMAGED DURING SURGERY (PRIOR TO INSERTION OF SHELL LINER). SURGEON DAMAGED LOCK RING. BECAUSE OF THIS DAMAGE, THE LINER WOULD NOT LOCK IN SHELL. SURGEON REPLACED SHELL WITH ANOTHER SHELL AND A NEW SHELL LINER WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP SYSTEM ACETABULAR SHELL Implant ACETABULAR SHELL (METAL BACKING) KWB ENCORE ORTHOPEDICS, INC. * 139691

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other