BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PFN

    MDR report key: 9713694 · Received February 14, 2020

    Report

    Report Number
    8030965-2020-01159
    Event Type
    Injury
    Date Received
    February 14, 2020
    Date of Event
    May 10, 2017
    Report Date
    February 6, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: PFN/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: KOSOLA J, KAIPIA A, LAITINEN MK, NIEMINEN (2017), COMPLICATIONS AFTER SURGICAL TREATMENT OF FEMORAL NECK FRACTURES IN MEN WITH ALCOHOL DEPENDENCE SYNDROME: RETROSPECTIVE REGISTER ANALYSIS OF 154 CASES, ARCH ORTHOP TRAUMA SURG, VOLUME 137, PAGE 967-973, (FINLAND). THE PURPOSE OF THIS RETROSPECTIVE REGISTER STUDY WAS TO EVALUATE THE TRENDS AND RESULTS ASSOCIATED WITH DIFFERENT SURGICAL METHODS TO TREAT NONDISPLACED AND DISPLACED FEMORAL NECK FRACTURES IN MALE PATIENTS WITH ALCOHOL DEPENDENCE SYNDROME (ADS). BETWEEN JANUARY 1, 2002, AND DECEMBER 31, 2014, 154 MALE PATIENTS WITH FEMORAL NECK FRACTURES WHO UNDERWENT SURGICAL TREATMENT, WERE INCLUDED IN THE STUDY. THE MEDIAN AGE OF THE PATIENTS WAS 64 YEARS (RANGE 29¿94 YEARS). 42 PATIENTS HAD TOTAL HIP ARTHROPLASTY, 76 PATIENTS HAD HEMIARTHROPLASTY, 12 PATIENTS WERE TREATED USING CANNULATED SCREWS, AND 24 PATIENTS HAD A SLIDING HIP SCREW. THE FOLLOWING OSTEOSYNTHETIC MATERIALS WERE USED: UNKNOWN SYNTHES DYNAMIC HIP SCREW, UNKNOWNS SYNTHES PROXIMAL FEMORAL NAIL, AND COMPETITOR DEVICES. THE MEAN FOLLOW-UP WAS 40 MONTHS. COMPLICATIONS WERE REPORTED AS FOLLOWS: (SLIDING HIP SCREW) 3 PATIENTS HAD REVISION DUE TO IMPLANT FAILURE. (CANNULATED SCREWS) 7 PATIENTS HAD REVISION DUE TO IMPLANT FAILURE. THIS REPORT IS FOR THE UNKNOWN SYNTHES PROXIMAL FEMORAL NAILS. IT CAPTURES THE REPORTED EVENT OF REVISION DUE TO IMPLANT FAILURE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176792 UNK - CONSTRUCTS: PFN ROD, FIXATION, INTRAMEDULLARY HSB OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention