BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTER-OP ACETABULAR SHELL

    MDR report key: 328239 · Received April 20, 2001

    Report

    Report Number
    MW1021678
    Event Type
    Injury
    Date Received
    April 20, 2001
    Date of Event
    April 11, 2001
    Report Date
    April 20, 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 ORTHOPEDICS, INC INTER-OP ACETABULAR SHELL IMPLANT. THE DEVICE WAS EXPLANTED. PREOPERATIVE DIAGNOSIS: FAILURE OF RIGHT HIP REPLACEMENT DUE TO FAILURE OF ACETABULAR INGROWTH. POSTOPERATIVE DIAGNOSIS: FAILURE OF RIGHT HIP REPLACEMENT DUE TO FAILURE OF ACETABULAR INGROWTH. PROCEDURE: REVISION OF RIGHT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18069 INTER-OP ACETABULAR SHELL HEMIS POR SHELL W/ SEALED SCREWHOLES SZ53MM KWB SULZER ORTHOPEDICS, INC. * 1421112

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention