BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTER-OP ACETABULAR SHELL

    MDR report key: 311086 · Received January 3, 2001

    Report

    Report Number
    MW1020750
    Event Type
    Injury
    Date Received
    January 3, 2001
    Date of Event
    December 5, 2000
    Report Date
    January 3, 2001
    Manufacturer
    SULZER MEDICA, 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. FOUR MONTHS LATER THE IMPLANTED DEVICE WAS EXPLANTED. PT'S PREOPERATIVE DIAGNOSIS WAS "LOOSE ACETABULUM LEFT HIP." PT EXPERIENCED PAIN IN THE LEFT HIP WITH X-RAY EVIDENCE THAT ACETABULUM HAD SHIFTED. AT SURGERY, THE ACETABULUM WAS GROSSLY SHIFTED. THERE WAS NO EVIDENCE OF ANY IN-GROWTH ANYWHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244 INTER-OP ACETABULAR SHELL HEMIS POR SHELL W/ SEALED SCREWHOLES SZ53MM KWB SULZER MEDICA, SULZER ORTHOPEDICS, INC. * 1426627

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R