BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CROSSFIRE 0 DEG INSERT

    MDR report key: 8813324 · Received July 22, 2019

    Report

    Report Number
    0002249697-2019-02623
    Event Type
    Injury
    Date Received
    July 22, 2019
    Date of Event
    June 25, 2019
    Report Date
    July 22, 2019
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    UDI-DI
    04546540037169
    PMA / PMN Number
    K974685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICE WAS ALSO LISTED IN THIS REPORT: OSTEONICS C-TAPER ZIRCONIA HD; CAT# 16-2805; LOT# SM6001 IT CANNOT BE DETERMINED, IF THIS DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE EVALUATED BY MFR: DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO PAIN (POSSIBLE CAUSE OR CONTRIBUTOR FOR PAIN NOT REPORTED TO REP). THE HEAD AND LINER WERE EXCHANGED. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608265 CROSSFIRE 0 DEG INSERT PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH 1RWKD 04546540037169

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R