BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTER-OP ACETABULAR SHELL

    MDR report key: 328792 · Received April 20, 2001

    Report

    Report Number
    MW1021688
    Event Type
    Injury
    Date Received
    April 20, 2001
    Date of Event
    March 9, 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 IN 2000 AT AN INSTITUTION OTHER THAN THE ONE LISTED ON THIS REPORT MODEL NUMBER AND LOT NUMBER UNK. IN 2001, THE DEVICE WAS EXPLANTED. PREOPERATIVE DIAGNOSIS: FAILED SULZER ACETABULUM, RIGHT TOTAL HIP REPLACEMENT. POSTOPERATIVE DIAGNOSIS: SAME PROCEDURE PERFORMED: REVISION, ACETABULUM, RIGHT TOTAL HIP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18124 INTER-OP ACETABULAR SHELL UNK KWB SULZER ORTHOPEDICS, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention