BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-05102

    MDR report key: 3310859 · Received August 27, 2013

    Report

    Report Number
    2520274-2013-05102
    Event Type
    Injury
    Date Received
    August 27, 2013
    Report Date
    July 31, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    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. DATE OF EVENT: 2012; 35(4): 345-353. PMA/501K: CANNOT BE DETERMINED WITHOUT A PART NUMBER. 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.

    Description of Event or Problem · 1

    JOURNAL ARTICLE RECEIVED: COMPLICATIONS OF CEMENT-AUGMENTED DYNAMIC HIP SCREWS IN UNSTABLE TYPE INTERTROCHANTERIC FRACTURES ¿ A CASE SERIES STUDY; CHANG GUNG MEDICAL JOURNAL, 2012; 35(4): 345-353. AUTHORS: MENG-HUANG WU, MD; PO-CHENG LEE, MD; KUO-TI PENG, MD, PHD; CHI-CHUAN WU, MD; TSUNG-JEN HUANG, MD; ROBERT WEN-WEI HSU, MD. THIS STUDY WAS TO INVESTIGATE THE COMPLICATIONS IN PMMA CEMENT-AUGMENTED DYNAMIC HIP SCREWS. SIXTY-SEVEN PATIENTS WERE INCLUDED IN THE STUDY (25 MEN, 42 WOMEN) WITH A MEAN AGE OF 81.2 YEARS. OF THESE, SIX PATIENTS HAD DELAYED OR NONUNION WITH SIDE PLATE FAILURES, ONE EXPERIENCED DEEP INFECTION AND ONE EXPERIENCED OSTEONECROSIS AT THE FEMORAL HEAD. THIS PATIENT HAD SCREW BREAKAGE AFTER 5 MONTHS AND WAS TREATED WITH SIDE PLATE EXCHANGE. IT IS UNKNOWN IF THIS WAS A SYNTHES DEVICE. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419349 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention