BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTER-OP ACETABULAR SHELL

    MDR report key: 338638 · Received June 18, 2001

    Report

    Report Number
    MW1022198
    Event Type
    Injury
    Date Received
    June 18, 2001
    Date of Event
    June 8, 2001
    Report Date
    June 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 ORTHOPEDICS, INC INTER-OP ACETABULAR SYSTEM THE DEVICE WAS EXPLANTED. POSTOPERATIVE DIAGNOSIS: FAILED SULZER ACETABULUM, RIGHT TOTAL HIP. POSTOPERATIVE DIAGNOSIS: SAME. PROCEDURE: REVISION ACETABULUM, RIGHT TOTAL HIP. PT HAS HAD PROGRESSIVE INCREASE IN PAIN IN THE HIP. THERE IS RADIOLOGIC EVIDENCE OF PROGRESSIVE LUCENCY ABOUT THE ACETABULUM, PARTICULARLY IN THE LAUENSTEIN VIEW. THE CUP WAS NOT AFFIXED TO THE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27693 INTER-OP ACETABULAR SHELL HEMIS POR SHELL W/ SZ55MM SCREWHOLES KWB SULZER ORTHOPEDICS, INC. * 1411550

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention