BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

    MDR report key: 3760076 · Received April 18, 2014

    Report

    Report Number
    2520274-2014-10878
    Event Type
    Injury
    Date Received
    April 18, 2014
    Report Date
    April 9, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    KTW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT FOR DIAGNOSIS. STERN, R., ET. AL., (2011, MARCH), PROSPECTIVE RANDOMISED STUDY COMPARING SCREW VERSUS HELICAL BLADE IN THE TREATMENT OF LOW-ENERGY TROCHANTERIC FRACTURES, INTERNATIONAL THIS REPORT IS FOR AN UNKNOWN PROXIMAL FEMORAL NAIL ANTIROTATION BLADE. 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: STERN, R., ET. AL., (2011, MARCH), PROSPECTIVE RANDOMISED STUDY COMPARING SCREW VERSUS HELICAL BLADE IN THE TREATMENT OF LOW-ENERGY TROCHANTERIC FRACTURES, INTERNATIONAL ORTHOPAEDICS, 35, 1855-1861. THE PURPOSE OF THIS ARTICLE WAS TO COMPARE FEMORAL HEAD PLACEMENT, RATES OF REOPERATION AND CEPHALIC IMPLANT CUT-OUT OF A SCREW VERSUS A BLADE FOR PATIENTS OVER AGE 60 WITH LOW ENERGY TROCHANTERIC FRACTURES TREATED WITH SLIDING HIP SCREW OR CEPHALOMEDULLARY NAIL. MULTIPLE SYNTHES DEVICES WERE USED IN THIS STUDY, DYNAMIC HIP SYSTEM SCREW, DYNAMIC HIP SYSTEM BLADE, AND A PROXIMAL FEMORAL NAIL ANTIROTATION. THERE WERE A TOTAL OF 335 PATIENTS, 89 PATIENTS RECEIVED THE DYNAMIC HIP SYSTEM SCREW, 89 PATIENTS RECEIVED THE GAMMA3 NAIL, 84 PATIENTS RECEIVED THE DYNAMIC HIP SYSTEM BLADE, AND 79 PATIENTS RECEIVED THE PROXIMAL FEMORAL NAIL ANTIROTATION. THE STUDY TOOK PLACE BETWEEN OCTOBER 2006 AND JULY 2009. OUTCOME MEASUREMENTS INCLUDED TIP-APEX DISTANCE AND ZONE LOCATION OF THE CEPHALIC IMPLANT, AS WELL AS REOPERATION AND IMPLANT CUT-OUT WITHIN THE FIRST YEAR POSTOPERATIVE. THE REPORTED COMPLICATIONS THAT REQUIRED A REOPERATION ARE: THE BLADE GROUP (DYNAMIC HIP SYSTEM BLADE AND PROXIMAL FEMORAL NAIL ANTIROTATION), 2 CUT-OUTS, ONE FOR THE DYNAMIC HIP SYSTEM BLADE AND ONE FOR THE PROXIMAL FEMORAL NAIL ANTIROTATION, ONE NON-UNION, TWO IMPLANT PERFORATION OF HEAD, AND ONE SUPERFICIAL WOUND INFECTION. THE SCREW GROUP (DYNAMIC HIP SYSTEM SCREW AND GAMMA3) COMPLICATIONS ARE TWO MIGRATIONS, ONE SUPERFICIAL WOUND INFECTION, AND TWO NON-UNIONS. THE TWO NON-UNIONS ARE GROUPED WITH THE DYNAMIC HIP SYSTEM SCREW AND GAMMA3 THEREFORE IT IS UNKNOWN IF THE SYNTHES PRODUCT CAUSED THE NON-UNION. IT WAS REPORTED THAT THERE WASN¿T A SIGNIFICANT DIFFERENCE BETWEEN THE TWO GROUPS FOR TIP-APEX DISTANCE, AND PATIENTS WITH A CENTRE-CENTRE POSITION OF THE CEPHALIC IMPLANT. THE AUTHOR CONCLUDED THAT BOTH SCREW AND BLADE PERFORMED EQUALLY WELL IN TERMS OF IMPLANT PLACEMENT IN THE FEMORAL HEAD AND OUTCOME. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. NON-UNION; 5 OF 8 MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236815 APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTW SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention