BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAG SCREW, TI 10.5X95MM

    MDR report key: 2243394 · Received August 18, 2011

    Report

    Report Number
    9610622-2011-00375
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 26, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K032244
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED TO THE HOSPITAL PRESENTING WITH EDEMA, SWOLLEN LEGS, AND FREQUENT FALLS. THE PATIENT HAS A HISTORY OF AN OPEN REDUCTION INTERNAL TROCHANTERIC NAIL FIXATION OF A LEFT HIP FRACTURE. THE NAIL WAS ORIGINALLY IN EXCELLENT POSITION. HOWEVER, THE HIP FRACTURE BEGAN TO COMPRESS OVER THE MONTHS AND THE LAG SCREW BEGAN TO MIGRATE LATERALLY AS THE HIP PROGRESSED. EXAMINATION FINDINGS WERE THAT THE LAG SCREW WAS SOMEWHAT PROMINENT. THE MD ADVISED THE PATIENT OF THE POSSIBLE NEED OF HARDWARE REVISION OR REPLACEMENT AND IT WAS POSSIBLE THAT OTHER RECONSTRUCTIVE PROCEDURES MIGHT NEED TO BE DONE IN THE FUTURE. THE MD ALSO GAVE THE PATIENT FOLLOW UP INSTRUCTIONS, BUT THE PATIENT HAD APPARENTLY MISSED SEVERAL VISITS AND HAD NOT BEEN SEEN IN THE OFFICE. HOWEVER, A RECENT CT OF HER PELVIS, PRESUMABLY TO EVALUATE THE SWELLING IN HER LEG, REVEALED THAT THE TROCHANTERIC NAIL REMAINS IN GOOD POSITION, THE DISTAL LOCKING SCREW REMAINS IN GOOD POSITION, BUT THE LAG SCREW HAS MIGRATED PROXIMALLY THROUGH THE TROCHANTERIC NAIL, AND IS NOW LODGED IN THE HEAD AND NECK OF THE FEMUR, TRAVERSING THE ACETABULUM, AND EXTENDS APPROXIMATELY 4 CM INTO THE ACETABULUM. THE PATIENT DENIES ANY BLOOD IN HER URINE OR ANY CHANGE IN HER BOWEL HABITS. THE DEVICE WAS IMPLANT IN (B)(6) 2010 AND EXPLANTED IN (B)(6) 2011. EXACT DATES WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREW, TI 10.5X95MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K288284

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R