BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTER-OP ACETABULAR SHELL

    MDR report key: 318180 · Received February 26, 2001

    Report

    Report Number
    MW1021211
    Event Type
    Injury
    Date Received
    February 26, 2001
    Date of Event
    February 19, 2001
    Report Date
    February 26, 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 IN 2000. IN 2001, THE IMPLANTED DEVICE WAS EXPLANTED. PT'S PRE-OPERATIVE DIAGNOSIS WAS "FAILED ACETABULAR COMPONENT, LEFT TOTAL HIP REPLACEMENT". THE OPERATIVE FINDINGS WERE "THE CUP WAS GROSSLY LOOSE. THERE WAS A TREMENDOUS AMOUNT OF INFLAMED TISSUE ABOUT THE HIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7668 INTER-OP ACETABULAR SHELL HEMIS POR SHELL W/ SEALED SCREWHOLES SZ53MM KWB SULZER MEDICA, SULZER ORTHOPEDICS, INC. * 1444040

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R