BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 2355835 · Received November 22, 2011

    Report

    Report Number
    2520274-2011-00752
    Event Type
    Injury
    Date Received
    November 22, 2011
    Report Date
    October 31, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM (B)(4) REPORTED, A PROXIMAL FEMUR FRACTURE STUDY REPORTED THE FOLLOWING: DURING A PERIOD OF 30 MONTHS ((B)(6) 2008-(B)(6) 2010) 52 PATIENTS PRESENTING WITH AN PER OR SUBTROCHANTERIC FRACTURE OF THE FEMUR WERE TREATED IN OUR INSTITUTION. NINETEEN CASES (12 MALE, 7 FEMALE) WITH A MEAN AGE OF (B)(6) (RANGE (B)(6) YRS) HAD OSTEOSYNTHESIS WITH PF-LCP. POSTOPERATIVELY PARTIAL WEIGHT BEARING WAS ALLOWED. FOLLOW UP EXAMINATION WITH CLINICAL AND RADIOLOGICAL EVAL TOOK PLACE AT 3,6 AND 12 MONTHS POSTOPERATIVELY. RESULTS AND CONCLUSIONS: SURGERY WAS PERFORMED IN ALL PTS WITHOUT INTRAOPERATIVE COMPLICATIONS. REASONABLE REDUCTION AND STABLE FIXATION WAS ACHIEVED IN 18 CASES. ONE CASE HAD TO BE REVISED IMMEDIATELY BECAUSE OF AD LATUS MAL-ALIGNMENT. IN 5 CASES SECONDARY LOSS OF REDUCTION WAS OBJECTED DURING THE 3 OR 6 MONTHS FOLLOW UP. REVISION SURGERY WITH CONDYLAR PLATE RE-OSTEOSYNTHESIS WAS PERFORMED IN 4 CASES AND TOTAL HIP PROSTHESIS IN 2 CASES. IN ONE CASE THE PROXIMAL SCREW HAD TO BE CHANGED BECAUSE OF LOOSENING. THREE OUT OF EIGHT PTS UNDERWENT HARDWARE REMOVAL COMPLAINING ABOUT PERSISTENT TROCHANTERIC PAIN. ONE PT DIED UNRELATED TO SURGERY. OUR EARLY RESULTS SHOW A HIGH MAJOR COMPLICATION RATE (37%) WITH RE-OSTEOSYNTHESIS OR PROSTHESIS IMPLANTATION DUE TO SECONDARY LOSS OF REDUCTION. CONSISTING TROCHANTERIC PAIN WAS OBJECTED LEADING TO HARDWARE REMOVAL 21% (3/8). FAILURE ANALYSIS INDICATES THAT A PRESERVED MEDIAL HINGE SEEMS TO BE A CRUCIAL KEY STONE IN ACHIEVING STABLE CONSOLIDATION. FURTHER CLINICAL AND BIOMECHANICAL TESTING IS NEEDED TO EVALUATE THE LIMITATION OF THIS DEVICE FOR THE TREATMENT OF UNSTABLE TROCHANTERIC FRACTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention