BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM PROVISIONAL FEMORAL HEAD

    MDR report key: 1833640 · Received September 8, 2010

    Report

    Report Number
    1822565-2010-00666
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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 DURING A TRIAL REDUCTION, WHEN TESTING FOR ANTERIOR DISLOCATION, THE STEM DISLOCATED ANTERIORLY WELL PAST AN ACCEPTABLE ANGLE AND THE HEAD SLIPPED UNDER THE HIP CAPSULE AND THEN DISLODGED FROM THE TRIAL NECK AND COULD NOT BE REMOVED FROM THE PT. SURGERY WAS PROLONGED FOR ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSYS HIP SYSTEM PROVISIONAL FEMORAL HEAD HIP INSTRUMENT LPH ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other