BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMI POR SHL W/SEALED SCWHLS SZ55MM I-O

    MDR report key: 331057 · Received April 20, 2001

    Report

    Report Number
    2935620-2001-00773
    Event Type
    Injury
    Date Received
    April 20, 2001
    Date of Event
    January 29, 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

    PT REC'D A SULZER MEDICA-SULZER ORTHOPEDICS, INC.- INTER-OP ACETABULAR SHELL IMPLANT IN 2000. ON THE EVENT DATE THE IMPLANTED DEVICE WAS EXPLANTED. PT'S PRE-OPERATIVE AND POST-OPERATIVE DIAGNOSES WERE "FAILED ACETABULAR COMPONENT RIGHT HIP". THE PROCEDURE WAS "REVISION ACETABULAR COMPONENT RIGHT TOTAL HIP REPLACEMENT." THE OPERATIVE REPORT STATES "THE ACETABULAR COMPONENT HAD COMPLETELY ERODED AND ROTATED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18359 HEMI POR SHL W/SEALED SCWHLS SZ55MM I-O HIP PROSTHESIS LPH SULZER ORTHOPEDICS, INC. NA 1414650

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R