BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS FEMORAL HEAD

    MDR report key: 3940582 · Received June 25, 2014

    Report

    Report Number
    2648920-2014-00161
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 THE PATIENT WAS REVISED DUE TO LOOSENING. IT IS ALSO REPORTED THAT THE PATIENT UNDERWENT A DEBRIDEMENT ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369717 VERSYS FEMORAL HEAD LPH ZIMMER 62257825

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention