BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12MM PRESS FIT BOWED STEM 150

    MDR report key: 2885235 · Received December 18, 2012

    Report

    Report Number
    2249697-2012-02728
    Event Type
    Injury
    Date Received
    December 18, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K022403
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BONE WAS BROKEN DURING IMPLANTING THE STEM. IT WAS REPORTED THAT THE SURGEON USED THE STEM IN THE PROXIMAL FEMUR OP. AFTER THE REMOVING OF THE BONE, THE SURGEON REAMED THE CANAL FROM 9MM WITH FLEXIBLE REAMER. THE REAMING SIZE WAS INCREASED BY 0.5MM. THE SURGEON PLANNED TO IMPLANT THE PF 12MM 150MM CURVED STEM, SO HE STOPPED REAMING AT 11.5MM. 12MM TRIAL WAS INSERTED AT THE MIDDLE. SO, HE REAMED AGAIN TO 12MM. THEN, HE USED THE 11MM TRIAL WITH HIS HAND TO CONFIRM THE LENGTH AND THE STABILITY OF THE LEG. THE 11MM TRIAL WAS INSERTED COMPLETELY. HE DID NOT USE THE FACING REAMER. AND 12MM IMPLANT WAS INSERTED WITH THE INSTRUMENT AND HE CONFIRMED THAT THE REMAINING 5MM COULD NOT BE INSERTED. BUT, HE CONTINUED TO IMPACT THE 12MM IMPLANT AND THE FRACTURE OF THE SHAFT OF FEMUR OCCURRED. TWO WIRES WERE USED FOR THE FRACTURE AND THE STEM WAS NOT IMPACTED MORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12MM PRESS FIT BOWED STEM 150 IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA 101107AA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other