BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIRUS NAIL FOR FEMUR

    MDR report key: 2140384 · Received June 16, 2011

    Report

    Report Number
    9613350-2011-00388
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 15, 2011
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS FORWARDED FROM THE OWNER ESTABLISHMENT, ZIMMER INC., WHICH MARKETS THE DEVICES IN THE UNITED STATES. THE MFR DID NOT RECEIVE EXPLANTED DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. IT IS NOT SUSPECTED THAT DEVICE FAILURE HAS LEAD TO THE ALLEGED EVENT. AS SOON AS ADDITIONAL INFO HAS BECOME AVAILABLE AND/OR THE DEVICE(S) WERE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT IS AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. THE NEED FOR FURTHER CORRECTIVE MEASURES IS NOT INDICATED AT THIS TIME AND ZIMMER GMBH CONSIDERS THIS CASE CLOSED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT UNDERWENT REVISION DUE TO BREAKAGE OF THE NAIL. IT IS ALSO REPORTED THAT PT WAS PULLING ON DIFFERENT PARTS FAIRLY HARD. AFTER THAT SHE STARTED TO HAVE SEVERE MUSCLE SPASMS IN LEFT THIGH AND SHE HAD TO RETURN TO USING A WALKER TO STAND AND PUT WEIGHT ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIRUS NAIL FOR FEMUR SIRUS INTRAMEDULLARY NAIL-FEMORAL HSB ZIMMER GMBH 08.398276

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Hospitalization| O