BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER MMC CUP 66MM/58MM CODE X

    MDR report key: 2792309 · Received October 12, 2012

    Report

    Report Number
    9613350-2012-00960
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 20, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS ON THE WAY TO THE MANUFACTURER FOR REVIEW. ONCE THE DEVICE IS RECEIVED AND FOR EVALUATION AND THE INVESTIGATION RESULT BECOMES AVAILABLE, WE WILL SUBMIT A FOLLOW UP REPORT. THERE IS NO NEED FOR CORRECTIVE MEASURE AT THIS POINT IN TIME. (B)(4).

    Description of Event or Problem · 1

    A MALE PATIENT RECEIVED AN MMC CUP ON (B)(6) 2010. THE PATIENT "COMPLAINED OF PAIN, AND HAS ELEVATED COCR LEVELS". ON (B)(6) 2012, THE PATIENT UNDERWENT REVISION SURGERY DUE TO "SUSPECTED METAL ON METAL SENSITIVITY ISSUES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER MMC CUP 66MM/58MM CODE X MOMOBLOCK METASUL COMPONENT JDI ZIMMER GMBH 2513363

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R