BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD,FIXATION,INTRAMEDULLARY

    MDR report key: 5841393 · Received August 2, 2016

    Report

    Report Number
    2520274-2016-13788
    Event Type
    Injury
    Date Received
    August 2, 2016
    Report Date
    July 6, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    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. TYLLIANAKIS, A. ET ALL (2004). TREATMENT OF EXTRACAPSULAR HIP FRACTURES WITH THE FEMORAL NAIL (PNF): LONG TERM RESULTS IN 45 PATIENTS. ACTA ORTHOAEDICA BELGICA., 70, 444-454. GREECE. THIS REPORT IS FOR AN UNKNOWN ANTI-ROTATIONAL HIP PIN IMPLANTED WITH AN UNKNOWN PROXIMAL FEMORAL NAIL SYSTEM, UNKNOWN QUANTITY, UNKNOWN LOT. OTHER NUMBER: 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. 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

    LITERATURE ARTICLE RECEIVED: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE): TYLLIANAKIS, A. ET ALL (2004). TREATMENT OF EXTRACAPSULAR HIP FRACTURES WITH THE FEMORAL NAIL (PNF): LONG TERM RESULTS IN 45 PATIENTS. ACTA ORTHOAEDICA BELGICA., 70, 444-454. GREECE. THE AUTHORS RETROSPECTIVELY STUDIED THE RESULTS ACHIEVED WITH THE AO/ASIF PFN (PROXIMAL FEMORAL NAIL) SYSTEM IMPLANTED TO TREAT UNSTABLE INTERTROCHANTERIC FRACTURES OF THE PROXIMAL FEMUR. 45 PATIENTS (28 WOMEN, 17 MEN, AVERAGE AGE 72 YEARS; RANGE 29 TO 93 YEARS) WERE FOLLOWED BETWEEN JUNE 1999 AND FEBRUARY 2003 (MEAN FOLLOW UP PERIOD WAS 20 MONTHS). INTRAOPERATIVE DIFFICULTIES IN THE INSERTION OF THE NAIL OR SCREWS, FRACTURE CONSOLIDATION, TECHNICAL OR MECHANICAL COMPLICATIONS AND DELAYED UNION, NONUNION AND AVASCULAR NECROSIS WERE REGISTERED. OF 45 PATIENTS 6 EXPERIENCED POST-OPERATIVE COMPLICATIONS: FOUR (4) PATIENTS HAD "Z EFFECTS" OF THE ANTIROTATIONAL HIP PIN LEADING TO FEMORAL HEAD PROTRUSION AND WAS REVISED WITH A LONG PFN IMPLANT. ONE (1) PATIENT HAD REVERSE "Z EFFECTS THAT DID NOT LEAD TO PROTRUSION AS THE HIP PIN WAS QUITE SHORT. ONE (1) PATIENT HAD REVERSE "Z EFFECTS "WAS MANAGED WITH REMOVAL OF THE ANTIROTATIONAL HIP PIN. THIS IS REPORT 4 OF 4 FOR (B)(4). THIS IS FOR AN ANTI-ROTATIONAL HIP PIN IMPLANTED WITH AN UNKNOWN PROXIMAL FEMORAL NAIL SYSTEM AND REFERS TO "Z EFFECTS" (THE HIP PIN PROTRUDED INTO THE ACETABULUM) OF THE ANTIROTATIONAL HIP PIN LEADING TO FEMORAL HEAD PROTRUSION, REVISION WITH LONG PFN IMPLANT, REVERSE "Z EFFECTS THAT DID NOT LEAD TO PROTRUSION AS THE HIP PIN WAS QUITE SHORT, AND REVERSE "Z EFFECTS THAT "WAS MANAGED WITH REMOVAL OF THE ANTIROTATIONAL HIP PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492865 ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention