BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

    MDR report key: 5100141 · Received September 24, 2015

    Report

    Report Number
    2520274-2015-15997
    Event Type
    Death
    Date Received
    September 24, 2015
    Report Date
    September 9, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. TAN, B; LAU, A; KWEK, E (2015) MORPHOLOGY AND FIXATION PITFALLS OF A HIGHLY UNSTABLE INTERTROCHANTERIC FRACTURE VARIANT. JOURNAL OF ORTHOPAEDIC SURGERY 23:2 142-145. THIS REPORT IS FOR AN UNKNOWN PFNA, PFLP OR LISS(UNKNOWN QUANTITY/UNKNOWN LOT). PLATE, FIXATION, BONE: HRS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: TAN, B; LAU, A; KWEK, E (2015) MORPHOLOGY AND FIXATION PITFALLS OF A HIGHLY UNSTABLE INTERTROCHANTERIC FRACTURE VARIANT. JOURNAL OF ORTHOPAEDIC SURGERY 23:2 142-145. THIS STUDY DESCRIBES THE RADIOLOGICAL MORPHOLOGY AND POTENTIAL FIXATION PITFALLS OF A VARIANT OF INTERTRO-CHANTERIC FRACTURE NOT WELL-CHARACTERISED IN THE EXISTING CLASSIFICATION SYSTEMS. RECORDS OF 200 PATIENTS WITH INTERTROCHANTERIC FRACTURES TREATED BETWEEN APRIL 2011 AND MARCH 2012 WERE REVIEWED. OF THESE, FRACTURES IN 10 WOMEN AND 2 MEN AGED 59 TO 98 (MEDIAN, 80 YEARS) WERE CHARACTERISED BY (1) A LOW INTERTROCHAN-TERIC FRACTURE, (2) A BASICERVICAL FRACTURE FRAGMENT, AND (3) A THIN OR FRACTURED LATERAL WALL WITH GREATER TROCHANTERIC COMMINUTION. THE 12 PATIENTS WERE TREATED WITH THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA N=5), THE PROXIMAL FEMUR LOCKING PLATE (PFLP N=6), OR THE REVERSED LESS INVASIVE STABILIZATION SYSTEM FOR DISTAL FEMUR (LISS, N=1). ALL IMPLANTS WERE MANUFACTURED BY SYNTHES. MECHANICAL FAILURE WAS DEFINED AS LOSS OF ALIGNMENT OF >10º OR SCREW CUTOUT. WITHIN THE MEAN FOLLOW-UP PERIOD OF 6 MONTHS, 3 PATIENTS WHO UNDERWENT PLATING AND ONE PATIENT WHO UNDERWENT NAILING HAD MECHANICAL FAILURE. THE LATTER ALSO HAD A CONCURRENT PERI-PROSTHETIC FRACTURE AFTER A FALL. ANOTHER PATIENT WHO UNDERWENT NAILING DEVELOPED AVASCULAR NECROSIS OF THE FEMORAL HEAD AT 7 MONTHS. ONE PATIENT DIED AT 2 WEEKS FROM AN UNRELATED CAUSE. ONE PATIENT DIED AT 2 MONTHS FROM IMPLANT INFECTION. THIS INTERTROCHANTERIC FRACTURE VARIANT IS HIGHLY UNSTABLE WITH A HIGH FAILURE RATE. LOSS OF SUPEROLATERAL SUPPORT RATHER THAN THE MEDIAL CALCAR BUTTRESS IS THE MAIN CONTRIBUTING FACTOR TO MECHANICAL FAILURE. COMPUTED TOMOGRAPHY IS IMPORTANT IN PREOPERATIVE PLANNING. INTRAMEDULLARY NAILING IS MORE APPROPRIATE THAN EXTRAMEDULLARY PLATING FOR SUCH UNSTABLE FRACTURES. THIS REPORT IS 4 OF 4 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN PFNA, PFLP OR LISS AND REFERS TO ONE UNKNOWN PATIENT WHO DIED AT 2 MONTHS FROM IMPLANT INFECTION. IMPLANT DEVICE NOT SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631571 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R