BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-05908

    MDR report key: 3329808 · Received September 6, 2013

    Report

    Report Number
    2520274-2013-05908
    Event Type
    Injury
    Date Received
    September 6, 2013
    Date of Event
    November 10, 2010
    Report Date
    August 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT: 2011 JUL; 42(7):675-681. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS RECEIVED TITLED: TREATMENT OF IPSILATERAL CONCOMITANT FRACTURES OF PROXIMAL EXTRA CAPSULAR AND DISTAL FEMUR. INJURY. 2011 JUL; 42(7):675-681. AUTHORS: GAO K, GAO W, LI F, TAO J, HUANG J, LI H, WANG Q. THE ARTICLE REPORTS: DURING A NON-RANDOMISED RETROSPECTIVE ANALYSIS FROM AUGUST 2002 TO JANUARY 2010, SEVEN PATIENTS (SIX MALES AND ONE FEMALE) WITH A MEAN AGE OF 39 YEARS (RANGE, 20¿48 YEARS) WERE INVOLVED IN THE STUDY. THEY HAD SUFFERED FROM IPSILATERAL CONCOMITANT FRACTURES OF PROXIMAL EXTRACAPSULAR AND DISTAL FEMUR, PATIENTS WERE OBSERVED FOR OUTCOMES OF THESE COMPLEX INJURIES. REPORTEDLY ONE PATIENT, A (B)(6) MALE, INVOLVED IN A TRAFFIC ACCIDENT WITH PROXIMAL FEMORAL FRACTURE A FLOATING KNEE INJURY DEVELOPED A DELAYED UNION IN THE SUBTROCHANTERIC AREA SIX MONTHS AFTER SURGERY DUE TO METAL FAILURE. THE PLATE AND SCREWS BACKED OUT AND EVENTUALLY PRODUCED A MALUNION WITH A COXA VARA DEFORMITY ONE AND HALF YEARS LATER. THE PATIENT REFUSED REVISION SURGERY. NO FEMORAL HEAD OSTEONECROSIS WAS OBSERVED AND NOT LIMB DISCREPANCY WAS OBSERVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNKNOWN SCREW. IT IS NOT KNOWN IF SYNTHES PRODUCTS WERE USED. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442942 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention