BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIZE 2 ACCOLADE II 127 DEG

    MDR report key: 3944450 · Received July 18, 2014

    Report

    Report Number
    0002249697-2014-02798
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K143085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. PATIENT DETAILS WERE REVIEWED AND NO INDICATION WAS FOUND THAT THE EVENT WAS RELATED TO DEVICE DESIGN, MATERIALS, OR MANUFACTURING. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER AND LOT CODE WERE NOT PROVIDED. THE DEVICE WAS REPORTED AS AN UNKNOWN ACCOLADE II STEM SIZE 2 STD. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO FOOT DROP AND LEG LENGTH DISCREPANCY SO STEM AND HEAD WERE REMOVED AND RE-IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO FOOT DROP AND LEG LENGTH DISCREPANCY SO STEM AND HEAD WERE REMOVED AND RE-IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421796 SIZE 2 ACCOLADE II 127 DEG IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 47103009

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R