BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3800155 · Received May 8, 2014

    Report

    Report Number
    2520274-2014-11280
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 24, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT FOR DIAGNOSIS. : MCCORMACK R, ET. AL., (2013), A MULTICENTRE, PROSPECTIVE, RANDOMISED COMPARISON OF THE SLIDING HIP SCREW WITH THE MEDOFF SLIDING SCREW AND SIDE PLATE FOR UNSTABLE INTERTROCHANTERIC HIP FRACTURES., INJURY, 44, 1904-1909. THIS REPORT IS FOR AN UNKNOWN PLATE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 JOURNAL ARTICLE: MCCORMACK R, ET. AL., (2013), A MULTICENTRE, PROSPECTIVE, RANDOMISED COMPARISON OF THE SLIDING HIP SCREW WITH THE MEDOFF SLIDING SCREW AND SIDE PLATE FOR UNSTABLE INTERTROCHANTERIC HIP FRACTURES., INJURY, 44, 1904-1909. THIS STUDY AIMED TO COMPARE THE DYNAMIC HIP SCREW AND MEDOFF SLIDING PLATE FOR UNSTABLE INTERTROCHANTERIC HIP FRACTURES. A TOTAL OF 163 PATIENTS WITH UNSTABLE INTERTROCHANTERIC HIP FRACTURES WERE RANDOMIZED TO DYNAMIC HIP SCREW OR MEDOFF SLIDING PLATE. A TOTAL OF 86 PATIENTS WERE RANDOMIZED TO DYNAMIC HIP SCREW AND 77 TO MEDOFF SLIDING PLATE. FOLLOW-UP ASSESSMENTS WERE PERFORMED AT REGULAR INTERVALS FOR A MINIMUM OF 6 MONTHS. IN THE SLIDING HIP SCREW GROUP, THERE WERE REOPERATIONS FOR HARDWARE FAILURE AND REMOVAL OF THE DEVICE, A LOSS OF REDUCTION OF THE FRACTURE AND A NON-UNION. IN THIS STUDY, THE TWO TECHNIQUES PRODUCED SIMILAR RESULTS IN TERMS OF RE-OPERATION RATES AND PATIENT FUNCTION. ON THE BASIS OF THESE RESULTS, THE TWO TECHNIQUES APPEAR TO BE EQUIVALENT, IMPLYING THAT THE SURGEON CAN JUSTIFY EITHER IMPLANT AND THAT THE CHOICE CAN BE BASED ON OTHER FACTORS SUCH AS COST AND SURGEON PREFERENCE. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. 3 OF 4 MEDWATCH

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279219 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention