BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5841480 · Received August 2, 2016

    Report

    Report Number
    2520274-2016-13816
    Event Type
    Injury
    Date Received
    August 2, 2016
    Report Date
    July 7, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT: TAN, B., KIANG LAU, C., KEE KWEK, E. (2015). MORPHOLOGY AND FIXATION PITFALLS OF A HIGHLY UNSTABLE INTERTROCHANTERIC FRACTURE VARIANT. JOURNAL OF ORTHOPAEDIC SURGERY, 23, 142-145. SINGAPORE. THIS REPORT IS FOR UNKNOWN SYNTHES PROXIMAL FEMUR LOCKING PLATE FOR DISTAL FEMUR, UNKNOWN QUANTITY, UNKNOWN LOT. ADDITIONAL COMMON DEVICE NAME: SCREW, FIXATION, BONE. ADDITIONAL DEVICE PRODUCT CODE: HWC. OTHER NUMBER: UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. 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 REPORTS IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: TAN, B., KIANG LAU, C., KEE KWEK, E. (2015). MORPHOLOGY AND FIXATION PITFALLS OF A HIGHLY UNSTABLE INTERTROCHANTERIC FRACTURE VARIANT. JOURNAL OF ORTHOPAEDIC SURGERY, 23, 142-145. SINGAPORE. THE AUTHORS RETROSPECTIVELY REVIEWED RECORDS OF 200 PATIENTS WITH INTERTROCHANTERIC FRACTURES TREATED BETWEEN APRIL 2011 AND MARCH 2012 (MEAN FOLLOW UP PERIOD OF 6 MONTHS). OF THE 200 PATIENTS, THE FRACTURES IN 10 WOMEN AND 2 MEN (AGED 59 TO 98, MEDIAN AGE 80 YEARS) WERE CHARACTERIZED BY A LOW INTERTROCHANTERIC FRACTURE, A BASICERVICAL FRACTURE FRAGMENT, AND A THIN OR FRACTURED LATERAL WALL WITH GREATER TROCHANTERIC COMMINUTION. THESE 12 PATIENTS WERE TREATED WITH THE PROXIMAL FEMORAL NAIL ANTIROTATIONAL, THE PROXIMAL FEMUR LOCKING PLATE, OR THE REVERSED LESS INVASIVE STABILIZATION SYSTEM FOR DISTAL FEMUR; ALL IMPLANTS WERE MANUFACTURED BY SYNTHES. OF THE 12 PATIENTS 1 EXPERIENCED COMPLICATIONS: 1 PATIENT, WHO UNDERWENT A PLATING WITH THE PROXIMAL FEMUR LOCKING PLATE DEVELOPED A MALUNION. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 3 OF 4 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SYNTHES PROXIMAL FEMUR LOCKING PLATE FOR DISTAL FEMUR AND REFERS TO 1 PATIENT, WHO UNDERWENT A PLATING WITH THE PROXIMAL FEMUR LOCKING PLATE DEVELOPED A MALUNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492690 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention