BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAP PLATE SCREWS

    MDR report key: 7930380 · Received October 3, 2018

    Report

    Report Number
    0002249697-2018-03171
    Event Type
    Injury
    Date Received
    October 3, 2018
    Date of Event
    September 5, 2018
    Report Date
    October 3, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    UDI-DI
    07613327037111
    PMA / PMN Number
    K943549
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO SHELL LOOSENING. A 58MM HEMISPHERICAL SHELL, 4 SCREWS, AND A 40F POLY LINER WERE REVISED TO A 62MM HEMISPHERICAL SHELL WITH 5 SCREWS AND A 40G POLY LINER. THE HEAD AND STEM WERE AND REMAIN COMPETITOR DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770661 GAP PLATE SCREWS PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH 248102 07613327037111

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R