BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 5825520 · Received July 27, 2016

    Report

    Report Number
    2520274-2016-13663
    Event Type
    Injury
    Date Received
    July 27, 2016
    Report Date
    July 7, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS LITERATURE CITATION: UZEN, METIN AND ET. AL (2009). ¿LONG-TERM RADIOGRAPHIC COMPLICATIONS FOLLOWING TREATMENT OF UNSTABLE INTERTROCHANTERIC FEMORAL FRACTURES WITH THE PROXIMAL FEMORAL NAIL AND EFFECTS ON FUNCTIONAL RESULTS.¿ ACTA ORTHOP TRAUMATOL TURC 2009 43 (6):457-463 ISTANBUL ARTICLE. THIS REPORT IS FOR UNKNOWN SCREW, UNKNOWN QUANTITY, UNKNOWN LOT. UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, UZEN, METIN AND ET. AL (2009). "LONG-TERM RADIOGRAPHIC COMPLICATIONS FOLLOWING TREATMENT OF UNSTABLE INTERTROCHANTERIC FEMORAL FRACTURES WITH THE PROXIMAL FEMORAL NAIL AND EFFECTS ON FUNCTIONAL RESULTS." ACTA ORTHOP TRAUMATOL TURC 2009 43 (6):457-463 ISTANBUL ARTICLE. THE ARTICLE WAS BASED ON A STUDY OF COMPLICATIONS OF 35 PATIENTS (23 WOMEN AND 12 MEN) WHO SUSTAINED UNSTABLE INTERTROCHANTERIC HIP FRACTURES AND WERE TREATED WITH PROXIMAL FEMORAL NAIL ANTIROTATION SYSTEM (PFNA). PATIENTS WERE EVALUATED CLINICALLY AND RADIOGRAPHICALLY AND COMPLICATIONS WERE RECORDED. THE FOLLOWING COMPLICATIONS WERE NOTED FOR NON-IDENTIFIED PATIENTS: TWO (2) UNKNOWN PATIENTS WITH NON-UNION. SECONDARY VARUS DISPLACEMENT IN 9 UNKNOWN PATIENTS. CALCIFICATION AT THE TIP OF THE GREATER TROCHANTER IN 2 UNKNOWN PATIENTS. CUT-OUT OF THE PROXIMAL SCREWS IN 2 PATIENTS. SCREW LOOSENING DUE TO COLLAPSE OF FRACTURE SITE IN UNKNOWN NUMBER OF PATIENTS. "Z-EFFECT" (INFERIOR LAG SCREW MIGRATES LATERALLY AND THE SUPERIOR LAG SCREW MIGRATES MEDIALLY DURING PHYSIOLOGIC LOADING) IN UNKNOWN NUMBER OF PATIENTS. FIVE (5) UNKNOWN PATIENTS REQUIRED REVISION SURGERY DUE TO COMPLICATIONS. INFECTION TREATED WITH ANTIBIOTIC THERAPY AND DRESSING IN ONE PATIENT. THIS REPORT IS FOR AN UNKNOWN PROXIMAL FEMORAL NAIL ANTIROTATION SYSTEM (PFNA) AND UNKNOWN SCREW COMPONENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479789 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention