BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLOFIT IT ALLOCLASSIC SHELL, 54/JJ

    MDR report key: 3593327 · Received January 8, 2014

    Report

    Report Number
    9613350-2014-02308
    Event Type
    Other
    Date Received
    January 8, 2014
    Date of Event
    December 13, 2013
    Report Date
    December 13, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW AS THE PT HAS NOT BEEN REVISED. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFO PROVIDED. SHOULD ADDITIONAL INFO BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER CASE REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS IMPLANTED A ALLOFIT IT ALLOCLASSIC SHELL, 54/JJ ON THE RIGHT SIDE ON UNK DATE. CURRENTLY THE PT IS BEING MONITORED DUE TO LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14550 ALLOFIT IT ALLOCLASSIC SHELL, 54/JJ ALLOFIT IT ALLOCLASSIC SHELL LZO ZIMMER GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other