BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMI POR SHL W/SEALED SCWHLS SZ51MM I-O

    MDR report key: 331473 · Received April 20, 2001

    Report

    Report Number
    2935620-2001-00772
    Event Type
    Injury
    Date Received
    April 20, 2001
    Date of Event
    January 20, 2001
    Report Date
    March 20, 2001
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED: PT RECEIVED A SULZER MEDICA-SULZER ORTHOPEDICS, INC.- INTER-OP ACETABULAR SHELL IMPLANT IN 2000. IN 2001 THE IMPLANTED DEVICE WAS EXPLANTED. PT'S PREOPERATIVE DIAGNOSIS WAS "FAILED ACETABUALR COMPONENT RIGHT HIP", THE SURGICAL PROCEDURE WAS "REVISION ACETABULAR COMPONENT RIGHT HIP", THE OPERATIVE FINDINGS WERE THAT "THE COMPONENT WAS COMPLETELY LOOSE IN THE ACETABULUM. IT WAS ACTUALLY STARTING TO ERODE AWAY THE ANTERIOR ASPECT OF THE ACETABULUM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18483 HEMI POR SHL W/SEALED SCWHLS SZ51MM I-O HIP PROSTHESIS LPH SULZER ORTHOPEDICS, INC. NA 1436922

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R