BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: FNS

    MDR report key: 15726905 · Received November 4, 2022

    Report

    Report Number
    8030965-2022-09270
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    January 1, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. THIS REPORT IS FOR AN UNK - CONSTRUCTS: FNS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. INITIAL REPORTER NAME AND ADDRESS: (B)(6). COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: FISCHER J, ET AL. (2022), SUBTROCHANTERIC FRACTURES AS A COMPLICATION OF FEMORAL NECK SYSTEM, TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER SCHOOL OF MEDICINE (USA) THIS STUDY AIMS TO DETECT AN ASSOCIATION BETWEEN THE FIXATION METHOD AND PERI-IMPLANT SUBTROCHANTERIC FEMORAL NECK FRACTURES. FROM JANUARY 2017 TO DECEMBER 2021, 69 PATIENTS (MEAN AGE OF 64 YEARS) TREATED WITH FEMORAL NECK FRACTURE WITH CLOSED REDUCTION INTERNAL FIXATION WERE INCLUDED IN THE STUDY. FIXATION INCLUDED UNKNOWN MANUFACTURER CANNULATED SCREWS IN 23 PATIENTS, UNKNOWN SYNTHES DYNAMIC HIP SCREW IN 11 PATIENTS AND UNKNOWN SYNTHES FEMORAL NECK SYSTEM IN 35 PATIENTS. COMPLICATIONS WERE REPORTED AS FOLLOWS: A TOTAL OF 4 PATIENTS IMPLANTED WITH THE UNKNOWN SYNTHES FEMORAL NECK SCREW HAD PERI-IMPLANTS SUBTROCHANTERIC FRACTURES INCLUDING A 68-YEAR-OLD FEMALE PATIENT. THIS REPORT IS FOR THE UNKNOWN SYNTHES FEMORAL NECK SYSTEM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4). A COPY OF THE CLINICAL EVALUATION FORM IS BEING SUBMITTED WITH THIS REGULATORY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522374 UNK - CONSTRUCTS: FNS ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention