BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2014-00669

    MDR report key: 3635288 · Received February 19, 2014

    Report

    Report Number
    2520274-2014-00669
    Event Type
    Injury
    Date Received
    February 19, 2014
    Report Date
    January 24, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN UNKNOWN PFN-A NAIL, QUANTITY 1. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. PLACEHOLDER.

    Description of Event or Problem · 1

    JOURNAL ARTICLE RECEIVED: WHICH IMPLANT IS BETTER FOR TREATING REVERSE OBLIQUITY FRACTURES OF THE PROXIMAL FEMUR: A STANDARD OR LONG NAIL? GUVENIR OKCU MD, NADIR OZKAYIN MD,CEMIL OKTA MD, ISMET TOPCU MD, KEMAL AKTUGLU MD; CLINICAL ORTHOPEDICS AND RELATED RESEARCH (2013) 471:2768¿2775; REPORTED: A PILOT PROSPECTIVE RANDOMIZED CONTROLLED TRIAL THAT COMPARED THE EFFECTS OF STANDARD VERSUS LONG INTRAMEDULLARY HIP NAILS, SYNTHES DEVICES PROXIMAL FEMORAL NAIL - ANTIROTATION (PFN-A), FOR THE TREATMENT OF REVERSE OBLIQUITY FRACTURES OF THE PROXIMAL FEMUR. PATIENTS WERE RANDOMIZED INTO TWO GROUPS: 18 PATIENTS (GROUP 1) WERE TREATED WITH A 130 DEGREE STANDARD PFN-A WHICH WAS 24 CM IN LENGTH AND 22 PATIENTS (GROUP 2) WERE TREATED WITH A 130 DEGREE LONG PFN-A IN VARIABLE LENGTHS RANGING FROM 34 TO 42 CM. THE MEAN PATIENT AGE WAS 79 YEARS. IT WAS NOTED THAT THREE PATIENTS IN GROUP 1 AND FOUR IN GROUP 2 SUBSEQUENTLY DIED (DATE AND CAUSE UNSPECIFIED). AVERAGE FOLLOW-UP RANGE FOR GROUP 1 AND 2 WAS 14 MONTHS AND 14.5 MONTHS RESPECTIVELY. IN GROUP 2, ONE PATIENT WAS REVISED DUE TO A DEEP INFECTION (GRADE IIIB COMPLICATION) AND SIX PATIENTS EXPERIENCED MALUNION. THE AUTHORS CONCLUDED THAT LONG PFN-A NAILS OFFERED NO CLINICAL ADVANTAGE COMPARED TO STANDARD PFN-A NAILS FOR THE TREATMENT OF REVERSE OBLIQUITY FRACTURES OF THE PROXIMAL FEMUR. THIS REPORT IS FOR AN UNKNOWN PFN-A NAIL. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104798 HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1