BEUDAMED
    FDA Adverse Event Other Summary report: N

    NCB PP DIST FEM PLATE, R, 12 H, L.278 MM

    MDR report key: 2891189 · Received December 21, 2012

    Report

    Report Number
    9613350-2012-01182
    Event Type
    Other
    Date Received
    December 21, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ZIMMER INC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITH THE INFO GIVEN SO FAR, NO INVESTIGATION IS POSSIBLE. ONCE WE RECEIVE MORE INFO, WE WILL SUBMIT AN UPDATED REPORT. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PT RECEIVED AN NCB PP DIST FEM PLATE, R, 12 H, L.278 MM. IT WAS REPORTED THAT THE SURGEON NOTED AFTER EVALUATING THE POST-OP X-RAYS, THAT THE "SCREWS HAD PASSED COMPLETELY THROUGH THE PLATE. THE PLATE WAS BENT SIGNIFICANTLY TO CONFORM TO IMPLANT ALREADY IN PLACE IN PT'S FEMUR." IT WAS ALSO REPORTED THAT "DURING PROCEDURE, SURGEON WAS UNABLE TO PLACE A LOCKING CAP ON THE SAME SCREW HOLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCB PP DIST FEM PLATE, R, 12 H, L.278 MM NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCK HRS ZIMMER INC 2642711

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R