BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN PIRIFORMIS FOSSA FEMORAL NAIL

    MDR report key: 2100539 · Received May 17, 2011

    Report

    Report Number
    1822565-2011-01200
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 21, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. NO PRODUCT WAS RETURNED FOR EVALUATION, OR X-RAYS PROVIDED TO ILLUSTRATE ISSUE. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DETERMINE LIKELY ROOT CAUSE. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFORMATION BE RECEIVED THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO WEEKS POST-OP, THE PATIENT WAS EXPERIENCING INCREASING GROIN PAIN. X-RAYS WERE TAKEN AND NO EVIDENCE OF FRACTURE WAS REPORTED. ONE WEEK LATER, THE PATIENT PRESENTED AT THE EMERGENCY ROOM WITH A DISPLACED FEMORAL NECK AFTER FALLING. THE NAIL WAS REPOSITIONED AND THE FRACTURE WAS REDUCED WITH THE USE OF FOUR SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZNN PIRIFORMIS FOSSA FEMORAL NAIL HSB ZIMMER INC 61223044

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention