BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCB PLATE FOR FEMUR

    MDR report key: 3192013 · Received June 20, 2013

    Report

    Report Number
    9613350-2013-01654
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. A PRODUCT FAILURE CAN NOT BE CONFIRMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR THE DEVICE(S) BE RETURNED FOR EVALUATION AND AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT TWO PROXIMAL SCREWS WITH ROUND HEADS HAVE PASSED THROUGH THE PLATE HOLES. THE PLATE HAS BROKEN AWAY FROM THE BONE, THE SCREWS ARE STILL IN THE BONE. PT UNDERWENT A REVISION SURGERY ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281248 NCB PLATE FOR FEMUR NCB PLATE FOR FEMUR, RIGHT, 9 HOLES HRS ZIMMER GMBH 2648343

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention