BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA Ø10 SM 125° L200 SST

    MDR report key: 3652874 · Received February 28, 2014

    Report

    Report Number
    2520274-2014-00922
    Event Type
    Injury
    Date Received
    February 28, 2014
    Report Date
    February 2, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THIS REPORT IS ON AN UNKNOWN NAIL, PART AND LOT NUMBERS ARE UNKNOWN. DATE OF EVENT: 2012. AUTHORS: E. SOUCANYE DE LANDEVOISIN, A. BERTANI, P. CANDONI, C. CHARPAIL, E. DEMORTIERE. ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH (2012) 98, 288¿295. PART NUMBER CANNOT BE CONFIRMED. WITHOUT A PART NUMBER THE 510K NUMBER CANNOT BE PROVIDED. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: PROXIMAL FEMORAL NAIL ANTIROTATION (PFN-ATM) FIXATION OF EXTRA-CAPSULAR PROXIMAL FEMORAL FRACTURES IN THE ELDERLY: RETROSPECTIVE STUDY IN 102 PATIENTS. THE BEST SURGICAL STRATEGY FOR EXTRA-CAPSULAR PROXIMAL FEMORAL FRACTURES (PFFS) IS CONTROVERSIAL IN THE ELDERLY. POOR BONE QUALITY AND NECK SCREW INSTABILITY CAN ADVERSELY AFFECT THE RESULTS WITH CURRENTLY AVAILABLE FIXATION DEVICES, WHICH PREDOMINANTLY CONSIST IN DYNAMIC HIP SCREW-PLATES AND PROXIMAL RECONSTRUCTION NAILS. THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFN-A, AO/ASIF) WAS DESIGNED TO MINIMISE THE RISK OF MECHANICAL COMPLICATIONS, AND PRELIMINARY RESULTS SUGGEST THAT THIS GOAL MAY HAVE BEEN ACHIEVED. WE CONDUCTED A SINGLE-CENTRE MULTI-SURGEON RETROSPECTIVE STUDY OF THE 108 PATIENTS OLDER THAN 70 YEARS WHO UNDERWENT PFN-A IMPLANTATION FOR NON-PATHOLOGICAL EXTRA-CAPSULAR PFFS BETWEEN JANUARY 2007 AND DECEMBER 2008. NONE OF THE PATIENTS WAS LOST TO FOLLOW-UP. SIX PATIENTS DIED DURING THE IMMEDIATE POSTOPERATIVE PERIOD AND WERE EXCLUDED FROM THE ANALYSIS. AT LAST FOLLOW-UP, 37 OF THE REMAINING PATIENTS HAD DIED; THE CLINICAL AND IMAGING DATA OBTAINED AT THE LAST VISIT IN THESE 37 PATIENTS WERE USED FOR THE STUDY. THUS, 102 FRACTURES MANAGED WITH PFN-ATM IN 102 PATIENTS WERE INCLUDED. DURING THE STUDY PERIOD, PFN-A WAS USED IN ALL PATIENTS OLDER THAN 70 YEARS OF AGE WHO HAD TRAUMA-RELATED EXTRACAPSULAR PFFS. THE 102 STUDY PATIENTS HAD A MEAN AGE OF 84.9 (70¿100 YEARS) AND A FEMALE-TO-MALE RATIO OF 2.8 (75 FEMALES AND 27 MALES). ALL THE STUDY PATIENTS HAD IMPLANTATION OF THE 200-MM NAIL MEASURING 10 MM IN DIAMETER AND HAVING A BLADE-NAIL ANGLE OF 125 DEGREES. ACTIVITY AND FUNCTION BEFORE THE INJURY WERE ASSESSED USING THE PARKER MOBILITY SCORE (PMS). AT LAST FOLLOW-UP, 65 (60 PERCENT) OF THE 108 OPERATED PATIENTS (50 FEMALES AND 15 MALES) WERE ALIVE. THE PFN-A DEVICE IS A PROXIMAL RECONSTRUCTION NAIL WHOSE IMPLANTATION IS SIMPLE AND FAST. THE HELICAL BLADE MAY CONFER ADDITIONAL BENEFITS IN PATIENTS WITH OSTEOPOROTIC TROCHANTERIC FRACTURES, BOTH BY PREVENTING ROTATION AND BY ENSURING CANCELLOUS BONE COMPACTION. THIS DESIGN MAY DIMINISH THE RATE OF COMPLICATIONS ASSOCIATED WITH THE CERVICAL IMPLANT, PROVIDED THE IMPLANTATION PROCEDURE IS SCRUPULOUSLY FOLLOWED AND FRACTURE REDUCTION IS OPTIMAL. OUR RESULTS SHOULD BE INTERPRETED WITH CAUTION UNTIL THE RESULTS OF AN ON-GOING PROSPECTIVE STUDY BECOME AVAILABLE. PATIENT COMPLICATIONS ASSOCIATED WITH THE PFN-A, WERE REPORTED AS: FEMORAL HEAD DISPLACEMENT, SURGICAL-SITE INFECTIONS REQUIRING REOPERATION, UNSTABLE FRACTURES REQUIRING REOPERATION, NAIL-RELATED FRACTURES AND LEG LENGTH INEQUALITY. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR A SERIOUS INJURY: A 79-YEAR-OLD WOMAN EXPERIENCED LEG LENGTH INEQUALITY DUE TO FEMORAL HEAD DISPLACEMENT WHICH LED TO REMOVAL OF THE NAIL AND TOTAL HIP ARTHROPLASTY AT ANOTHER INSTITUTION. MORE THAN 2 YEARS (50 MONTHS) LATER, SHE HAD NO PAIN AD HER PMS WAS 7 COMPARED TO 9 BEFORE THE INJURY. BASED UPON THE INFORMATION PROVIDED IN THE JOURNAL ARTICLE, (200MM NAIL MEASURING 10MM IN DIAMETER AND HAVING A BLADE-NAIL ANGLE OF 125 DEGREES, SYNTHES BELIEVES THE PART NUMBER IS MOST LIKELY 272.370S. THIS HAS NOT BEEN VERIFIED. THIS IS 4 OF 6 REPORTS FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124858 PFNA Ø10 SM 125° L200 SST HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention