BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM EPOCH FULLCOAT HIP PROSTHESIS FEMORAL STEM

    MDR report key: 788153 · Received November 27, 2006

    Report

    Report Number
    1822565-2006-00308
    Event Type
    Injury
    Date Received
    November 27, 2006
    Date of Event
    October 24, 2006
    Report Date
    November 14, 2006
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED USING A LINE-TO-LINE REAMING TECHNIQUE IN A TWO INCISION APPROACH. INITIALLY, THE CANAL WAS REAMED TO 14MM AND A 14LM RASP WAS USED. THE 14LM RASP FELT UNSTABLE, SO THE SURGEON REAMED UP TO 15MM AND RASPED WITH A 15LM RASP. THE 15LM RASP FELT STABLE, SO THE SIZE 15LM STEM WAS IMPACTED. UPON IMPACTION, THE STEM STOPPED APPROXIMATELY 1CM PROUD OF FULL SEATING. AFTER A PERIOD OF WAITING FOR THE BONE TO RELAX, THE SURGEON PROCEEDED TO SEAT THE STEM FULLY WITH ADDITIONAL MALLET BLOWS. AN INTRAOPERATIVE RADIOGRAPH FOUND THAT THERE WAS A DISTAL FEMORAL FRACTURE. THE FEMUR WAS CIRCLAGED WITH THREE CABLES AND THE STEM IS NOW STABLE. APPROXIMATELY 25 TO 30 MINUTES WERE ADDED TO THE SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM EPOCH FULLCOAT HIP PROSTHESIS FEMORAL STEM HIP PROSTHESIS JDI ZIMMER, INC. NA 60475168

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R