BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN CMN NAIL

    MDR report key: 2800967 · Received October 18, 2012

    Report

    Report Number
    9613350-2012-00987
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 23, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    PATIENT EXPERIENCING INCREASED PAIN AND EXTERNAL ROTATION OF THE RIGHT LEG. REVISION SURGERY COMPLETED FOR REMOVAL AND RE-IMPLANTATION OF FIXATION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZNN CMN NAIL ZNN CMN NAIL 10MMX36CM 130 R HSB ZIMMER GMBH 2521190

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R