BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4758292 · Received May 8, 2015

    Report

    Report Number
    2520274-2015-13682
    Event Type
    Injury
    Date Received
    May 8, 2015
    Report Date
    April 11, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). THIS REPORT IS FOR AN UNKNOWN DYNAMIC HIP SCREW/UNKNOWN QUANTITY/UNKNOWN LOT. 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, "INTERTROCHANTERIC OSTEOTOMY USING A DYNAMIC HIP SCREW FOR FEMORAL NECK NONUNION" (2005). HARTFORD, J.E., ET AL. J ORTHOP TRAUMA (2005;19;5: 329 - 333). EIGHT FEMORAL NECK NONUNIONS WERE TREATED WITH INTERTROCHANTERIC OSTEOTOMIES USING A DYNAMIC HIP SCREW (SYNTHES, (B)(4)) FOR FIXATION. ALL OPERATIONS WERE PERFORMED BY A SINGLE SURGEON WITH FELLOWSHIP TRAINING. SEVEN OF THE EIGHT PATIENTS WERE INITIALLY TREATED FOR THE FEMORAL NECK FRACTURES WITH PERCUTANEOUS SCREW FIXATION. THE EIGHTH PATIENT HAD AN IPSILATERAL FEMORAL SHAFT AND FEMORAL NECK FRACTURE IN WHICH THE FEMORAL NECK WAS TREATED WITH A FEMORAL RECONSTRUCTION NAIL AND SUPPLEMENTAL SCREWS. THE AVERAGE AGE OF THE PATIENTS AT THE TIME OF THE INTERTROCHANTERIC OSTEOTOMY WAS 46 YEARS (RANGE 30-65). THE AVERAGE WEIGHT WAS 175 POUNDS (RANGE 120-220). THE AVERAGE HEIGHT WAS 70 INCHES (RANGE 66-73). THERE WERE 6 MALES AND 2 FEMALES. THE AVERAGE TIME FROM TREATMENT OF THE INDEX FEMORAL NECK FRACTURE TO INTERTROCHANTERIC OSTEOTOMY WAS 10 MONTHS (RANGE 5-14). ONE PATIENT DIED AT 4 MONTHS POSTOPERATIVELY DUE TO A CEREBRAL VASCULAR ACCIDENT. NOT INCLUDING THIS PATIENT, THE AVERAGE LENGTH OF FOLLOW-UP WAS 24 MONTHS (RANGE 12-39). SEVEN OF THE 8 FEMORAL NECK NONUNIONS AND OSTEOTOMIES WERE HEALED BY RADIOGRAPHIC CRITERIA OF BRIDGING TRABECULAE AT 12 WEEKS. THE ONE PATIENT WHO EXPIRED AT 4 MONTHS DEMONSTRATED EVIDENCE OF HEALING RADIOGRAPHICALLY AND HAD DECREASED PAIN AND IMPROVED AMBULATION AT 6 WEEKS. POSTOPERATIVELY, FOUR OF THE 7 PATIENTS HAVE A TRENDELENBURG GAIT AND ONE PATIENT HAS PERSISTENT GROIN PAIN. A 66 YEAR OLD PATIENT HAS A 1.5 CM OF RESIDUAL SHORTENING OF THE FEMORAL NECK WITH A 1.5 CM LEG LENGTH DISCREPANCY. THE DEVICE HAS NOT BEEN REMOVED. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN DYNAMIC HIP SCREW. THIS MEDWATCH REFERS TO THE FOUR UNIDENTIFIABLE PATIENTS WHO HAVE A TRENDELENBURG GAIT AND ONE UNIDENTIFIABLE PATIENT THAT HAS PERSISTENT GROIN PAIN. (INTERTROCHANTERIC VALGUS OSTEOTOMY FOR FEMORAL NECK NONUNION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303056 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention