BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY FEMUR SIZE 3 LEFT

    MDR report key: 2682745 · Received July 31, 2012

    Report

    Report Number
    3005180920-2012-00041
    Event Type
    Injury
    Date Received
    July 31, 2012
    Date of Event
    July 2, 2012
    Report Date
    July 31, 2012
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK PRIMARY FEMUR SIZE 3 LEFT. (B)(4) / LOT 112975 (36 FEMURS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDING WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. NINETEEN ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. GMK PRIMARY UC INSERT SIZE 3 HEIGHT 10 MM: (B)(4) / LOT 112009 (60 LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDING WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THIRTY-NINE ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, THE EVENT IS HIGHLY UNLIKELY DEVICE RELATED, BUT THE KNEE INSTABILITY IS PROBABLY RELATED TO A SURGICAL MISTAKE DURING THE PRIMARY SURGERY.

    Description of Event or Problem · 1

    PT COMPLAINED OF UNSTABLE KNEE. SURGEON DECIDED TO REPLACE STD FEMUR AND UC INSERT WITH PS FEMUR AND PS INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMK PRIMARY FEMUR SIZE 3 LEFT KNEE FEMORAL COMPONENTS JWH MEDACTA INTERNATIONAL SA 112975

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention (B)(4) / LOT 112009| GMK PRIMARY UC INSERT: