BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTER-OP ACETABULAR SHELL

    MDR report key: 328237 · Received April 18, 2001

    Report

    Report Number
    MW1021677
    Event Type
    Injury
    Date Received
    April 18, 2001
    Date of Event
    March 9, 2001
    Report Date
    April 18, 2001
    Manufacturer
    SULZER ORTHOPEDICS, INC.
    Product Code
    KWB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A SULZER MEDICA - SULZER ORTHOPEDICS, INC - INTER-OP ACETABULAR SHELL IMPLANT. THE IMPLANTED DEVICE WAS EXPLANTED. PREOPERATIVE DIAGNOSIS: FAILED ACETABULUM LEFT TOTAL HIP REPLACEMENT. THE ACETABULUM SHOWED NO EVIDENCE OF ANY BONY INGROWTH. PROCEDURE: REVISION OF FAILED SULZER ACETABULUM LEFT TOTAL HIP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17884 INTER-OP ACETABULAR SHELL HEMIS PORUS SHELL W/ SEALED SCREWHOLES SZ 57MM KWB SULZER ORTHOPEDICS, INC. * 1421113

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention