BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD,FIXATION,INTRAMEDULLARY

    MDR report key: 4823994 · Received June 8, 2015

    Report

    Report Number
    2520274-2015-14294
    Event Type
    Injury
    Date Received
    June 8, 2015
    Report Date
    June 4, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN PROXIMAL FEMORAL NAIL ANTIROTATION SYSTEM. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICES WERE RETURNED AND NO LOT NUMBERS OR PART NUMBERS WERE PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE ¿ FACTORS INFLUENCING FUNCTIONAL OUTCOMES IN UNITED INTERTROCHANTERIC HIP FRACTURES: A NEGATIVE EFFECT OF LAG SCREW SLIDING.¿ CHANG, J., KIM, T., KWAK, Y., KWON, Y., YOO, J. (2014) (SOUTH KOREA) THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE FACTORS INFLUENCING FUNCTIONAL OUTCOMES IN ELDERLY PATIENTS WITH UNITED INTERTROCHANTERIC FRACTURES TREATED WITH HIP NAILS AND TO ASCERTAIN WHETHER DECREASED FEMORAL OFFSET DUE TO LAG SCREW SLIDING HAS A NEGATIVE EFFECT ON FUNCTIONAL OUTCOMES IN PATIENTS. BETWEEN NOVEMBER 2008 TO FEBRUARY 2011, 65 PATIENTS OLDER THAN 65 YEARS WITH UNITED INTERCHANTERIC FRACTURS. 37 PATIENTS WERE TREATED WITH HIP NAILS (PROXIMAL FEMORAL NAIL ANTIROTATION; SYNTHES) AND 28 PATIENTS WERE TREATED WITH A COMPETITOR PRODUCT, THE MEAN FOLLOW UP WAS 20.7 MONTHS. GOOD REDUCTION WAS MET IN 51 PATIENTS. MEAN LAG SCREW SLIDING DISTANCE WAS 5.3MM IN THE PFNA GROUP. MORE LAG SCREW SLIDING OCCURRED AS BONE MINERAL DENSITY DECREASED. IT WAS ALSO GREATER IN UNSTABLE FRACTURES AND ACCEPTABLE REDUCTION STATUS. MODERATE PAIN WAS REPORTED BY 47% OF THE PATIENTS WHEREAS 53% HAD MILD PAIN. THIS REPORT IS FOR AN UNKNOWN PROXIMAL FEMORAL NAIL ANTIROTATION SYSTEM. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368833 ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention