BEUDAMED
    FDA Adverse Event Other Summary report: N

    NCB PP DIST FE PLATE, R, 9 H, L. 238MM

    MDR report key: 2845023 · Received November 8, 2012

    Report

    Report Number
    9613350-2012-01052
    Event Type
    Other
    Date Received
    November 8, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ZIMMER GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE SINCE THE PATIENT HAS NOT BEEN REVISED TO DATE. THE LOT NUMBER FOR THE DEVICE HAS BEEN RECEIVED AND THE DEVICE HISTORY QUALITY RECORDS WERE REVIEWED. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATED THAT THIS COMPONENT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. A CAUSE FOR THIS SPECIFIC CLINICAL EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. WE WILL SUBMIT AN UPDATED REPORT, ONCE THE PATIENT HAS UNDERGONE REVISION SURGERY AND THE DEVICE IS RETURNED TO THE MANUFACTURER. (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE NCB PLATE BROKE IN SITU. NCB. WEIGHT BEARING WITH BRACE IS TOLERATED POST SURGERY. REVISION SURGERY IS BEING PLANNED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCB PP DIST FE PLATE, R, 9 H, L. 238MM NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCK HRS ZIMMER GMBH 2619381

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other