BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4303345 · Received December 8, 2014

    Report

    Report Number
    2520274-2014-15105
    Event Type
    Injury
    Date Received
    December 8, 2014
    Report Date
    November 17, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LEUNG, F. ET AL. (2012). DYNAMIC HIP SCREW BLADE FIXATION FOR INTERTROCHANTERIC HIP FRACTURES. JOURNAL OF ORTHOPAEDIC SURGERY, 20, 302-306. THIS REPORT IS FOR AN UNKNOWN DHS SYSTEM/UNKNOWN QUANTITY/UNKNOWN LOT. COMMON DEVICE NAME: PLATE, FIXATION, BONE; HRS. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: LEUNG, F. ET AL. (2012). DYNAMIC HIP SCREW BLADE FIXATION FOR INTERTROCHANTERIC HIP FRACTURES. JOURNAL OF ORTHOPAEDIC SURGERY, 20, 302-306. THE AUTHORS ASSESSED THE ONE YEAR OUTCOME OF SYNTHES DEVICE, THE DYNAMIC HIP SCREW (DHS) USING A FOUR HOLED 135 DEGREE ANGLED PLATE, IN THE TREATMENT OF INTERTROCHANTERIC HIP FRACTURES SUSTAINED AFTER LOW-ENERGY INJURY. FROM SEPTEMBER 2007 TO APRIL 2008, 35 MEN AND 65 WOMEN AGED 47 TO 110 (MEAN, 83 YEARS) WERE TREATED. POSTOPERATIVELY, PATIENTS WERE FOLLOWED UP AT SIX WEEKS, 12 WEEKS, SIX MONTHS AND ONE YEAR WITH THE USE OF RADIOGRAPHS, AND ASSESSMENT FOR FUNCTIONAL OUTCOME AND POTENTIAL COMPLICATIONS. AT ONE YEAR FOLLOW-UP, 81 PATIENTS WERE AVAILABLE AND ALL OF THEIR FRACTURES HAD HEALED. THE RESULTS INCLUDED: AN (B)(6) YEAR OLD FEMALE WITH LOSS OF FIXATION SECONDARY TO A NON-TRAUMATIC SUBCAPITAL FRACTURE AT THREE MONTHS FOR WHICH A BIPOLAR HEMIARTHROPLASTY WAS PERFORMED. ONE PATIENT DEVELOPED A LOCAL INFECTION; ONE PATIENT DEVELOPED A DEEP INFECTION. A COPY OF THE LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH. THIS REPORT IS 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN DHS SYSTEM AND REFERS TO AN (B)(6) YEAR OLD FEMALE WITH LOSS OF FIXATION SECONDARY TO A NON-TRAUMATIC SUBCAPITAL FRACTURE AT THREE MONTHS FOR WHICH A BIPOLAR HEMIARTHROPLASTY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789793 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention