BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4668702 · Received April 8, 2015

    Report

    Report Number
    2520274-2015-12589
    Event Type
    Injury
    Date Received
    April 8, 2015
    Report Date
    March 31, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LANGFORD, J., PILLAI, G., UGLIAILORO, A. D. , AND YANG, E (2011). ¿PERIOPERATIVE LATERAL TROCHANTERIC WALL FRACTURES: SLIDING HIP SCREW VERSUS PERCUTANEOUS COMPRESSION PLATE FOR INTERTROCHANTERIC HIP FRACTURES.¿ JOURNAL OF ORTHOPAEDIC TRAUMA. (25: 191-105). 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 JOURNAL ARTICLE, LANGFORD, J., PILLAI, G., UGLIAILORO, A. D. , AND YANG, E (2011). ¿PERIOPERATIVE LATERAL TROCHANTERIC WALL FRACTURES: SLIDING HIP SCREW VERSUS PERCUTANEOUS COMPRESSION PLATE FOR INTERTROCHANTERIC HIP FRACTURES.¿ JOURNAL OF ORTHOPAEDIC TRAUMA. (25: 191-105). UNITED STATES ARTICLE. THIS IS A RETROSPECTIVE RADIOLOGIC ANALYSIS OF A PROSPECTIVE TRAUMA REGISTRY FROM (B)(6) 2000 TO (B)(6) 2007 CONSISTING OF 337 PATIENTS WITH INTERTROCHANTERIC HIP FRACTURES THAT WERE TREATED WITH EITHER A SLIDING HIP SCREW (SHS) OR A PERCUTANEOUS COMPRESSION PLATE (PCCP) AT A LEVEL I TRAUMA CENTER. THE OBJECTIVE OF THE STUDY WAS TO DETERMINE THE INCIDENCE OF PERIOPERATIVE LATERAL WALL FRACTURES WITH A SHS VERSUS A PCCP USING IDENTICAL METICULOUS CLOSED REDUCTION TECHNIQUES IN BOTH GROUPS. THE PATIENTS WERE DIVIDED INTO TWO GROUPS BASED ON THE TYPE OF IMPLANT RECEIVED, EITHER SHS OR PCCP. GROUP 1 CONSISTED OF 141 PATIENTS, 105 WOMEN AND 39 MEN WITH AN AVERAGE AGE OF 81 YEARS OLD (RANGE 43-99) WHO RECEIVED A PCCP. GROUP 2 CONSISTED OF 100 PATIENTS, 73 WOMEN AND 27 MEN WITH AN AVERAGE AGE OF 77 YEARS OLD (RANGE 37-101) WHO RECEIVED EITHER A SYNTHES SHS OR A COMPETITORS SHS. RADIOLOGIC IMAGES WERE DONE PREOPERATIVE, INTRAOPERATIVE (INCLUDING REDUCTION FILM AND POST-IMPLANT PLACEMENT) AND POSTOPERATIVE. THE POSTOPERATIVE RADIOGRAPHS WERE TAKEN BETWEEN 7 AND 28 DAYS AFTER SURGERY. DURING INTRAOPERATIVE RADIOGRAPHS A LINE WAS DRAWN UP FROM THE LATERAL CORTEX OF THE FEMUR TO HELP DEFINE LATERAL WALL FRACTURES. ON LATER RADIOGRAPHS IF THE LINE UP THE LATERAL FEMUR WAS NOT CONTIGUOUS WITH THE LATERAL TROCHANTER, THEN A LATERAL WALL FRACTURE WAS RECORDED. THERE WAS AN OVERALL LATERAL WALL FRACTURE INCIDENCE OF 20 %(20 PATIENTS) IN THE SHS GROUP VERSUS 1.4 %(2 PATIENTS) IN THE PCCP GROUP. THERE WAS AN OVERALL LATERAL WALL FRACTURE INCIDENCE OF 20 %(20 PATIENTS) IN THE SHS GROUP. THIS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SLIDING HIP SCREW (SHS). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232094 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention