BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 5790954 · Received July 13, 2016

    Report

    Report Number
    2520274-2016-13463
    Event Type
    Malfunction
    Date Received
    July 13, 2016
    Report Date
    July 7, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. CHENG, L., JING, J., LI, J. THE ASIA PROXIMAL FEMORAL NAIL ANTIROTATION VERSUS THE STANDARD PROXIMAL FEMORAL ANTIROTATION NAIL FOR UNSTABLE INTERTROCHANTERIC FRACTURES IN ELDERLY CHINESE PATIENTS (2015) ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH 101, PP: 143-146. THIS REPORT IS FOR AN UNKNOWN PFNA 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CHENG, L., JING, J., LI, J. THE ASIA PROXIMAL FEMORAL NAIL ANTIROTATION VERSUS THE STANDARD PROXIMAL FEMORAL ANTIROTATION NAIL FOR UNSTABLE INTERTROCHANTERIC FRACTURES IN ELDERLY CHINESE PATIENTS (2015) ORTHOPAEDICS & TRAUMATOLOGY: SURGERY & RESEARCH 101, PP: 143-146. THIS ARTICLE HYPOTHESIZED THE RATE OF COMPLICATIONS USING PROXIMAL FEMORAL NAIL ANTI-ROTATION (PFNA-II) IS LOWER THAN PFNA FOR THE TREATMENT OF UNSTABLE INTERTROCHANTERIC FRACTURES IN ELDERLY CHINESE PATIENTS, AND THE OPERATION USING PFNA-II IS QUICKER. PATIENTS FROM JUNE 2008 TO DECEMBER 2011, 188 PATIENTS ABOVE THE AGE OF 60 WITH UNSTABLE INTERTROCHANTERIC FRACTURES WERE TREATED WITH A PFNA OR A PFNA-II (SYNTHES (B)(4)) FOLLOW-UP EVALUATIONS POST OPERATIVELY WERE PERFORMED AT 1, 3, 6, 9 AND 12MONTHS, AND EVERY YEAR THEREAFTER. TWO CUTOUTS OCCURRED IN THE PFNA GROUP. SEVERAL PATIENTS REPORTED THIGH PAIN DURING THE FOLLOW-UP PERIOD: 8 PATIENTS IN THE PFNA-II GROUP AND 18 IN THE PFNA GROUP. ONE PATIENT IN THE PFNA AND 1 PATIENT IN THE PFNA-II GROUP EXPERIENCED DEEP INFECTION. TEN PATIENTS IN THE PFNA-II GROUP AND 5 PATIENTS IN THE PFNA GROUP EXPERIENCED HEMATOMA. THIS REPORT IS FOR AN UNKNOWN PFNA SYSTEM. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS MEDWATCH WILL ADDRESS THE 2 CUTOUTS WHICH OCCURRED IN THE PFNA GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445668 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1