BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY FEMUR SIZE 4 LEFT

    MDR report key: 2682773 · Received July 31, 2012

    Report

    Report Number
    3005180920-2012-00044
    Event Type
    Injury
    Date Received
    July 31, 2012
    Date of Event
    July 18, 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 4 LEFT. (B)(4) / LOT 113382 (40 FEMURS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDING WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. TWENTY TWO ITEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. GMK PRIMARY UC INSERT SIZE 4 HEIGHT 10 MM: (B)(4) / LOT 114247 (50 LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDING WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. EIGHTEEN 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 MALPOSITIONING OF THE COMPONENTS IS PROBABLY DUE TO A SURGICAL MISTAKE DURING THE PRIMARY SURGERY.

    Description of Event or Problem · 1

    THE SURGEON WAS NOT SATISFIED WITH THE POSITION OF THE FEMORAL IMPLANT ON THE POST OP X-RAY OF THE PRIMARY TKA. A REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GMK PRIMARY FEMUR SIZE 4 LEFT KNEE FEMORAL COMPONENTS JWH MEDACTA INTERNATIONAL SA 113382

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention GMK PRIMARY UC INSERT:| (B)(4) / LOT 114247