BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZMR HIP XL TAPER STEM

    MDR report key: 2063172 · Received March 22, 2011

    Report

    Report Number
    1822565-2011-00699
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: VISUAL INSPECTION OF THE RETURNED SHELF CARTON AND PACKAGE SYSTEM INDICATED SEVERE ABUSE. THE CAUSE OF THE PUNCTURED TRAYS AND DAMAGE TO THE SHELF CARTON WAS EXPOSURE TO HAZARDS OUTSIDE OF NORMALLY ANTICIPATED DISTRIBUTION ENVIRONMENTS. EVALUATION: DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. NO MANUFACTURING ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE IMPLANT BOX WAS OPENED, IT WAS NOTED THAT THE IMPLANT HAD BROKEN THROUGH THE STERILE PACKAGING. THE SURGEON REAMED UP TO THE NEXT SIZE IMPLANT FOR COMPLETION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZMR HIP XL TAPER STEM LPH ZIMMER, INC. 60064407

    Patients

    Seq Age Sex Outcome Treatment
    1