BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER BONE SCREW

    MDR report key: 1844760 · Received September 23, 2010

    Report

    Report Number
    2648920-2010-00048
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ZIMMER
    Product Code
    LPH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SECOND TYVEK SHEET WAS SKINNED WHEN PULLING THE FIRST SHEET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER BONE SCREW HIP PROSTHESIS LPH ZIMMER 61436643

    Patients

    Seq Age Sex Outcome Treatment
    1