BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5094623 · Received September 22, 2015

    Report

    Report Number
    2520274-2015-16001
    Event Type
    Injury
    Date Received
    September 22, 2015
    Date of Event
    October 31, 2014
    Report Date
    September 4, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PUBLICATION DATE OF ARTICLE: OCTOBER 31, 2014. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ZEHIR S., ET AL.(2014). PROXIMAL FEMORAL NAIL ANTIROTATION AGAINST DYNAMIC HIP SCREW FOR UNSTABLE TROCHANTERIC FRACTURES; A PROSPECTIVE RANDOMIZED COMPARISON. EUR J TRAUMA EMERG SURG (2015) 41:393¿400. THIS REPORT IS FOR DYNAMIC HIP SCREWS, UNKNOWN QUANTITY, UNKNOWN LOT. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PERT NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE, ZEHIR S., ET AL.(2014). PROXIMAL FEMORAL NAIL ANTIROTATION AGAINST DYNAMIC HIP SCREW FOR UNSTABLE TROCHANTERIC FRACTURES; A PROSPECTIVE RANDOMIZED COMPARISON. EUR J TRAUMA EMERG SURG (2015) 41:393-400. THIS STUDY SOUGHT TO DETERMINE WHETHER INTRAMEDULLARY FIXATION WITH PROXIMAL FEMORAL NAIL ANTIROTATION PRODUCES COMPARABLE OUTCOMES TO DYNAMIC HIP SCREW IN THE TREATMENT OF UNSTABLE TROCHANTERIC FRACTURES. PATIENTS WERE RANDOMLY ALLOCATED TO RECEIVE PROXIMAL FEMORAL NAIL ANTIROTATION (GROUP 1) OR DYNAMIC HIP SCREW (GROUP 2). PATIENTS WERE RANDOMLY ALLOCATED TO RECEIVE PFNA (FIG. 2) ((B)(4)) (GROUP 1, N = 96, MEAN AGE; 77.22 +/-6.82 YEARS, MALE:FEMALE RATIO 0.62) OR DHS (FIG. 3) ((B)(4)) (GROUP 2, N = 102, MEAN AGE; 76.86 ᠶ.74, MALE:FEMALE RATIO 0.62) FOR OPERATIVE TREATMENT OF THE FRACTURE. THE STUDY WAS CONDUCTED IN A TERTIARY UNIVERSITY HOSPITAL AND THE STUDY GROUP COMPRISED PATIENTS WHO WERE OPERATED ON FOR UNSTABLE TROCHANTERIC FRACTURES BETWEEN JANUARY 2010 AND MARCH 2013. IN-HOSPITAL MORTALITY OCCURRED IN EIGHT PATIENTS WHO WERE AGED BETWEEN 72 AND 91 YEARS. SIX OF THESE DEATHS WERE DUE TO CARDIAC FAILURE AND TWO DUE TO SEPSIS AND MULTIORGAN FAILURE. THE FOLLOWING COMPLICATIONS WERE NOTED IN DHS GROUP: DEEP WOUND INFECTION(4), HEMATOMA(4), CUTOUT(8), PAIN AT HIP(3), PAIN AT THIGH(2), REOPERATION(3). THIS IS REPORT 1 OF 5 FOR (B)(4). THIS REPORT IS FOR DYNAMIC HIP SCREWS AND REFERS TO THE FOLLOWING COMPLICATIONS WERE NOTED IN DHS GROUP: DEEP WOUND INFECTION(4), HEMATOMA(4), PAIN AT HIP(3), PAIN AT THIGH(2), REOPERATION(3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627215 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention