BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTER-OP ACETABULAR SHELL

    MDR report key: 318174 · Received February 26, 2001

    Report

    Report Number
    MW1021210
    Event Type
    Injury
    Date Received
    February 26, 2001
    Date of Event
    February 20, 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. PRE-OPERATIVE DIAGNOSIS WAS "FAILED LEFT HIP REPLACEMENT DUE TO LACK OF OSTEOINCORPORATION OF THE ACETABULUM." THE OPERATIVE FINDING WAS "THE ACETABULUM WAS NOT GROSSLY LOOSE BUT IT WAS CLEARLY IMBEDDED IN SCAR TISSUE ONLY AND IT WAS REMOVED WITHOUT DIFFICULTY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7667 INTER-OP ACETABULAR SHELL HEMIS POR SHELL W/ SEALED SCREWHOLES SZ51MM KWB SULZER MEDICA, SULZER ORTHOPEDICS INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R