BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZMR HIP XL TAPER STEM

    MDR report key: 2042208 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00598
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    LPH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: NO PACKAGING MATERIALS REC'D TO REVIEW, ONLY PHOTO OF PRODUCT PROTRUDING THROUGH INNER CAVITY WAS PROVIDED. THE PHOTO INDICATES FORCES ABOVE NORMAL DISTRIBUTION ENVIRONMENT CONDITIONS. PRODUCT AS PACKAGED HAS BEEN TESTED TO NORMAL DISTRIBUTION CONDITIONS AND PASSED. PACKAGE TEST REPORT CONDUCTED ON THIS PACKAGE FOR ZMR HIP SYSTEMS SHOWED NO DAMAGE TO PACKAGE UNDER NORMAL DISTRIBUTION CONDITIONS. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MANUFACTURED AND INSPECTED TO SPECIFICATION. NO MFG ABNORMALITIES COULD BE DETECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HIP STEM WAS NOTED AS PROTRUDING THROUGH THE STERILE PACKAGING WHEN OPENED FOR SURGERY. THE SURGEON HAD TO USE A DIFFERENT SIZE OF STEM TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZMR HIP XL TAPER STEM LPH ZIMMER INC 60050984

    Patients

    Seq Age Sex Outcome Treatment
    1