BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2+ RIGHT

    MDR report key: 6819955 · Received August 25, 2017

    Report

    Report Number
    3005180920-2017-00473
    Event Type
    Injury
    Date Received
    August 25, 2017
    Date of Event
    July 28, 2016
    Report Date
    August 25, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862366
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 18 AUGUST 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: THE SINGLE IMAGE PROVIDED SHOWS THE PRESENCE OF A PROXIMAL TIBIAL FRACTURE. DUE TO THE LITTLE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DEFINE THE REAL CAUSE OF THIS EVENT. IT SEEMS THAT NO TRAUMATIC EVENT WAS REPORTED. PATIENT'S CHARACTERISTICS SUCH AS FEMALE GENDER AND AGE ((B)(6)) MAY BE ASSOCIATED TO THE BONE WEAKENING THAT COULD HAVE FAVOURED THE OCCURRENCE OF FRACTURE. HOWEVER, BASED ON THE AVAILABLE INFORMATION, THE REASON OF THIS EVENT CANNOT BE DETERMINED. BATCH REVIEW PERFORMED ON 22 AUGUST 2017. LOT 152903: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JULY 2015. EXPIRATION DATE: 2020-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    AFTER THE PRIMARY SURGERY, THE PATIENT ALLEGED THE PAIN. X-RAYS WAS TAKEN SEVERAL DAYS AFTER AND FOUND THE BONE FRACTURE. HOSPITALIZATION WAS PROLONGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602012 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2+ RIGHT FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 152903 07630030862366

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other