BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER NATURAL NAIL SYSTEM

    MDR report key: 3021135 · Received March 24, 2013

    Report

    Report Number
    3021135
    Event Type
    Malfunction
    Date Received
    March 24, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 22, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT STATES THAT HE HAS TENDERNESS LATERALLY WHERE THERE IS A SCREW PROTRUDING FROM HIS HARDWARE. PATIENT STATES THAT HE HAS FELT THIS PAIN AND KNOWN HIS SCREW TO BE BACKING OUT SINCE SIX MONTHS AFTER HIS SURGERY. IMAGING: X-RAYS WERE OBTAINED, WHICH DO SHOW HISTORY OF RIGHT INTERTROCHANTERIC FRACTURE WITH GAMMA NAIL, INCREASED ANGULATION OF THE FRACTURE SITE, AND PROTRUSION OF THE SCREWS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?RIGHT TOTAL HIP ARTHROPLASTY RIGHT HARDWARE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121196 ZIMMER NATURAL NAIL SYSTEM NAIL, FIXATION, BONE, METALLIC JDS ZIMMER, INC. CEPHALOMEDULLARY SHORT NAIL UNK
    121197 ZIMMER NATURAL NAIL SYSTEM SCREW, FIXATION, BONE, NON-SPINAL, METALLIC HWC ZIMMER, INC. LAG SCREW 10.5 MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR