BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK FIXED UC TIBIAL INSERT SIZE 1 - 12 MM

    MDR report key: 4416644 · Received January 9, 2015

    Report

    Report Number
    3005180920-2014-00201
    Event Type
    Injury
    Date Received
    January 9, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    DOCUMENT REVIEW: GMK PRIMARY UC FIXED TIBIAL INSERT SIZE 1 - 12 MM: REF. 02.07.0112FUC / LOT 110869 ((B)(4) DEVICES PRODUCED AND (B)(4) ALREADY SOLD WITHOUT ANY OTHER SIMILAR ISSUE REPORTED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. FROM THE DATA COLLECTED AND THE INFO RECEIVED, THERE ARE NO EVIDENCE THAT THE EVENT IS DEVICE RELATED, BUT IS LIKELY DUE TO A WRONG SIZE IMPLANTED DURING THE PRIMARY SURGERY.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21392 GMK FIXED UC TIBIAL INSERT SIZE 1 - 12 MM UC FIXED KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1