BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP CURVED CONDYLAR PLATE/14 HOLES/314MM-RIGHT

    MDR report key: 2171062 · Received July 8, 2011

    Report

    Report Number
    3003506883-2011-00045
    Event Type
    Injury
    Date Received
    July 8, 2011
    Report Date
    June 13, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K041911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT#: THIS INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    STATUS POST PERIPROSTHETIC MIDSHAFT FEMUR FRACTURE, DISTAL TO A TOTAL HIP. SECOND NON-UNION SURGERY. FIRST NON-UNION WAS ONE YEAR AGO. PATIENT COMPLAINED OF PAIN IN RIGHT FEMUR. REVISION DUE TO NONUNION. PATIENT REVISED TO PLATE AND SCREWS. THIS IS THE 1ST OF 18 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM LCP CURVED CONDYLAR PLATE/14 HOLES/314MM-RIGHT LCP CURVED CONDYLAR PLATE KTT SYNTHES ELMIRA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CABLES| SCREWS