BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTER-OP ACETABULAR SHELL

    MDR report key: 331337 · Received May 3, 2001

    Report

    Report Number
    MW1021817
    Event Type
    Injury
    Date Received
    May 3, 2001
    Date of Event
    March 15, 2001
    Report Date
    May 3, 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. THE DEVICE WAS EXPLANTED IN 2001. PREOPERATIVE DIAGNOSIS: FAILED ACETABULUM LEFT TOTAL HIP REPLACEMENT. POSTOPERATIVE DIAGNOSIS: FAILED ACETABULUM LEFT TOTAL HIP REPLACEMENT. PROCEDURE: REVISION ACETABULUM LEFT TOTAL HIP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20477 INTER-OP ACETABULAR SHELL HEMIS POR SHELL W/ SEALED SCREWHOLES SZ57MM KWB SULZER ORTHOPEDICS, INC. * 1430590

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention