BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE FIXED TIBIAL INSERT SIZE 5 14MM

    MDR report key: 4351163 · Received December 1, 2014

    Report

    Report Number
    3005180920-2014-00169
    Event Type
    Injury
    Date Received
    December 1, 2014
    Report Date
    July 30, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K130299
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GMK HINGE FIXED PE TIBIAL INSERT SIZE 5, 14 MM: CODE 02.09.0514H / LOT 120032 ((B)(4) ITEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. ONLY THIS ITEM OF THE LOT HAVE BEEN ALREADY SOLD. WE HAVE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION HAS BEEN RECEIVED CONCERNING OUTCOMES FOR THE PATIENT NOR ABOUT THE REVISION SURGERY, ALTHOUGH IT WAS REQUESTED SEVERAL TIMES.

    Description of Event or Problem · 1

    IMP REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774233 GMK HINGE FIXED TIBIAL INSERT SIZE 5 14MM KNEE FIXED PE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1