BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR DUAL MOBILITY INSERT

    MDR report key: 9383088 · Received November 27, 2019

    Report

    Report Number
    0002249697-2019-03887
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    May 6, 2019
    Report Date
    November 27, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    UDI-DI
    04546540666024
    PMA / PMN Number
    K103233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAS BEEN ONE OTHER SIMILAR EVENT FOR THE LOT REFERENCED FOR THE SAME DEVICE FOR THE SAME PATIENT. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THIS PI IS FOR THE CLOSED REDUCTION OF THE PATIENT'S RIGHT HIP ON (B)(6) 2019. AS PART OF THE DOCUMENTS PROVIDED FOR A REVISION OF PATIENT'S RIGHT HIP ON (B)(6) 2019 (PI 2231996), A DISCHARGE SUMMARY INDICATES A CLOSED REDUCTION WAS PERFORMED ON THE PATIENT'S RIGHT HIP FOR DISLOCATION ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179826 MODULAR DUAL MOBILITY INSERT PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO STRYKER ORTHOPAEDICS-MAHWAH 68781802 04546540666024

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R