BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSYS FEMORAL STEM BEADED FULLCOAT

    MDR report key: 2182639 · Received July 5, 2011

    Report

    Report Number
    1822565-2011-01593
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE RETURNED DEVICE MET SPECIFICATION WHERE MEASURED. THE METHOD OF INSPECTION BY THE USER IS UNK AND THE MEASURING INSTRUMENT USED (HOLE GAUGE) IS NOT RECOMMENDED OR ADVISED. THE CAUSE CANNOT BE DEFINITIVELY DETERMINED WITH THE INFO PROVIDED. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MFG AND INSPECTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SURGEON PREPARED THE FEMORAL CANAL TO IMPLANT A 16MM LM BEADED FULLCOAT. THE FEMORAL CANAL WAS REAMED TO 15.5MM AND RASPED WITH A 16MM BROACH. THE IMPLANT WAS OPENED AND THE DISTAL END WAS MEASURED. THE SURGEON FELT THAT THE IMPLANT WAS TOO SMALL, NOT ALLOWING FOR A TIGHT PRESSFIT. AS A RESULT, A LARGER DEVICE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS FEMORAL STEM BEADED FULLCOAT LPH ZIMMER, INC. 60080672

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR