BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSYS FEMORAL STEM POROUS FULLCOAT BOWED

    MDR report key: 2093570 · Received April 6, 2011

    Report

    Report Number
    1822565-2011-00868
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 18, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT IS UNKNOWN WHETHER PROPER INSTRUMENTS WERE USED DURING THE SURGERY OR NOT. THIS TYPE OF FAILURE MAY BE CAUSED DUE TO ONE OR A COMBINATION OF FOLLOWING FACTORS: IMPROPER SURGICAL TECHNIQUE. USE OF IMPROPER INSTRUMENTS. DULL CUTTING EDGES OF THE REAMER OR THE RASP. THIS IS NOT AN EXHAUSTIVE LIST. A CAUSE CANNOT BE DEFINITIVELY DETERMINED WITH THE INFORMATION PROVIDED. EVALUATION: THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND INDICATES THAT THE PART WAS MANUFACTURED, INSPECTED AND PACKAGED ACCORDING TO THE SPECIFICATION. THE RETURNED DEVICE WAS INSPECTED AND MEETS THE PROFILE TOLERANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON COULD NOT GET THE IMPLANT TO SEAT CORRECTLY AFTER HE REAMED TO 16.5MM TWICE WITH A FLEXIBLE REAMER TO A DEPTH OF 240MM. THE SURGEON DECIDED TO IMPLANT A STRAIGHT STEM INSTEAD OF THE ORIGINALLY PLANNED BOWED STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS FEMORAL STEM POROUS FULLCOAT BOWED LPH ZIMMER, INC. 60597819

    Patients

    Seq Age Sex Outcome Treatment
    1